Intimate care products: cosmetic, medical device or drug, and how to launch them
Which intimate products are cosmetics and which are regulated as medical devices or drugs, the pH and formulation basics, the claims that cause trouble, the tests to plan, and the rules on marketplaces and ad platforms.
Washes, wipes, deodorizing sprays and balms for the external intimate area are cosmetics: the EU Cosmetics Regulation covers products for the external genital organs, and the FDA's cosmetic categories include douches and feminine deodorants. Personal lubricants are medical devices: in the US they are Class II devices (product code NUC, cleared through 510(k) under 21 CFR 884.5300), and in the EU they are medical devices under Regulation (EU) 2017/745 that need a notified body; vaginal moisturizers and products placed inside the body are usually devices or drugs too. A cosmetic intimate wash should be mild, close to the skin's acidic pH (guidelines cited in the literature suggest about pH 4.2 to 5.6 for external washes), low in fragrance, and must not claim to prevent or treat infections, odor caused by infection, or vaginal flora problems. Ad platforms allow sexual and reproductive health products only with health-focused messaging and, on Meta, mostly 18+ targeting.
Cosmetic, medical device or drug
The same shelf in a pharmacy can hold products from three legal worlds. What decides the category is where the product is used, how it works and what it claims:
| Product | US | EU |
|---|---|---|
| External intimate wash or gel | Cosmetic (if claims are cleansing and freshness) | Cosmetic: the regulation covers external genital organs |
| Intimate wipes | Cosmetic | Cosmetic |
| Feminine deodorant spray | Cosmetic with a mandatory warning (21 CFR 740.12) | Cosmetic |
| Bikini-area after-shave or ingrown-hair care | Cosmetic if claims are about appearance and soothing | Cosmetic |
| Douche | Listed in the FDA cosmetic categories; claims about infections make it a drug | Depends on function and presentation; often not a cosmetic |
| Personal lubricant | Medical device, Class II, 510(k) | Medical device under the MDR, with a notified body |
| Vaginal moisturizer, vaginal gel | Usually a medical device (some are cleared together with lubricants) or a drug | Usually a medical device or a medicine |
| Anti-itch, antifungal or anti-infection products | Drug | Medicine |
Two legal anchors: the EU Cosmetics Regulation defines a cosmetic as a product for the external parts of the human body, listing the external genital organs among them, so anything used inside the vagina is outside cosmetics. In the US, a product is a drug if it is intended to treat or prevent disease or affect the structure or function of the body, and a device if it achieves its purpose mainly by physical means, such as a lubricant that reduces friction. See cosmetic vs drug claims.
Lubricants and vaginal moisturizers
- US. Personal lubricants are cleared by the FDA as Class II medical devices under product code NUC, using the condom regulation (21 CFR 884.5300) as their classification. A new lubricant needs a 510(k) premarket notification showing it is substantially equivalent to a legally marketed lubricant, with biocompatibility testing and, if you claim condom compatibility, condom compatibility testing. The maker must register as a device establishment and follow device quality system rules.
- EU. Personal lubricants are medical devices under the Medical Devices Regulation (Regulation (EU) 2017/745) since it applied in May 2021. Lubricant makers report that a notified body must assess them (manufacturers commonly report class IIb). They carry a CE mark, which a cosmetic never does.
- Vaginal moisturizers are regulated in the same way in most cases; some US products are cleared as "lubricant and vaginal moisturizer" devices.
- Massage oils sold for skin massage only are cosmetics, but once they are presented as lubricants for intimate use, they move into the device category.
A cosmetics manufacturer cannot simply add a lubricant to its range: the device route needs its own quality system, testing and registrations.
pH and formulation of intimate washes
The vulva and vagina have their own environment. A review of intimate hygiene practices (Chen and colleagues, Women's Health, 2017) reports a healthy vaginal pH of about 3.8 to 4.4 in women of reproductive age, higher before puberty and after menopause, and cites regional guidelines recommending a hypoallergenic liquid wash with mild detergency and a pH of 4.2 to 5.6 for external use, no bar soaps or bubble baths on the area, and no vaginal douching. The same review notes the UK Royal College of Obstetricians and Gynaecologists advises against soap, shower gel, scrubs and deodorant on the vulva.
- Mild surfactants
Amphoteric, glucoside or amino acid surfactants at low levels rather than strong sulfates; the wash should clean without stripping.
- Acidic pH
Formulate in a mildly acidic range (for example with lactic acid as a buffer) and fix the pH range in the specification so every batch is checked.
- No or very low fragrance
Fragrance and essential oils are common irritants on sensitive mucosa-adjacent skin. "Fragrance-free" versions sell well in this category; see fragrance-free formulating.
- Gentle, proven preservation
A tested preservative system that suits sensitive areas; prove it with a challenge test. See shelf life and preservatives.
- Soothing ingredients
Panthenol, allantoin, aloe, centella, bisabolol and similar ingredients support comfort claims about the skin.
- External use by design
Directions and pack design (pump, foam) should make external use obvious; no nozzles that suggest internal use for a cosmetic.
Claims to avoid
| Usually fine for a cosmetic (with evidence) | Avoid on a cosmetic (drug or device claims, or misleading) |
|---|---|
| "Gentle daily cleansing for the external intimate area" | "Prevents yeast infections", "prevents BV", "treats odor caused by infection" |
| "pH-balanced formula" (describing the wash's own pH) | "Restores vaginal pH", "balances vaginal flora", "probiotic for vaginal health" |
| "Fresh feeling", "neutralizes everyday odor on the skin" | "Antibacterial", "kills germs", "antifungal" |
| "Soothes dry, irritated-feeling skin after shaving" | "Relieves itching caused by infection", "heals" |
| "Fragrance-free", "dermatologist tested" or "gynecologist tested" (with the matching test) | "Tightening", "rejuvenating", "for arousal" (body function claims) |
One US rule is very specific: for feminine deodorant sprays, using the words "hygiene" or "hygienic" makes the product misbranded, and any words suggesting medical usefulness make it an illegal new drug (21 CFR 740.12). In the EU every claim must meet the common criteria of Regulation (EU) No 655/2013. Claim basics are in what skincare can claim.
Testing
| Test | Why |
|---|---|
| Stability and compatibility | Shelf life, pH stability over time, no interaction with the pump or bottle |
| Challenge test (ISO 11930) | Proves the preservative system |
| Microbiology per batch | Products used near mucous membranes are held to stricter microbial limits |
| Patch test or HRIPT | Skin tolerance; backs "dermatologist tested" |
| In-use test under gynecological supervision | Backs "gynecologist tested" and tolerance claims for the intended area |
| Device tests (lubricants only) | Biocompatibility, condom compatibility and other tests required for the 510(k) or MDR file; not cosmetic tests |
More in patch test and HRIPT and the testing overview.
Label rules
- Cosmetic label basics apply as for any cosmetic in each market: identity, net content, ingredients, responsible company, and in the EU the Responsible Person, function where not obvious, batch and date or PAO. See label requirements by country.
- "For external use only" and clear directions belong on every intimate cosmetic.
- US feminine deodorant sprays must carry the full caution statement in 21 CFR 740.12, which begins "Caution: For external use only." and includes not applying to broken, irritated or itching skin, consulting a physician about persistent unusual odor or discharge, and stopping if rash or irritation develops.
- Aerosols carry the pressurized container warnings and need dangerous goods handling in shipping; see shipping aerosols.
- Devices follow device labeling (in the EU a CE mark and notified body number, UDI and instructions; in the US device labeling rules), which is outside this guide.
Channel and ad rules
- Meta (Facebook and Instagram). Meta's advertising standards allow ads for sexual and reproductive health products when the focus is on health and the medical efficacy of the product, not on sexual pleasure or enhancement. Most of these ads must target people 18 or older, and lubricants are allowed with 18+ targeting; women's hygiene products are exempt from the 18+ requirement. See Instagram and Facebook shops and Meta ads.
- Amazon. Amazon has its own policies for sexual wellness products, explicit imagery and medical devices; lubricants are often reviewed as devices. Read the current restricted products pages in Seller Central before listing, and see selling skincare on Amazon.
- TikTok Shop and other marketplaces restrict sexual wellness and health claims; check each platform's prohibited and restricted product lists. See TikTok Shop.
- Creators. Influencer posts must follow the same claim rules as your label, plus disclosure rules for paid content.
Launch steps
- Classify each product
Cosmetic, device or drug in each market. Keep the first launch to cosmetics (wash, wipes, balm) unless you have a device partner.
- Write the claims first
Cleansing, freshness, comfort of the skin, fragrance-free, tested claims. No infection, flora or treatment claims.
- Brief the formula
Mild surfactants, acidic pH range, no or low fragrance, soothing ingredients, pump or foam pack.
- Test
Stability, challenge test, skin tolerance, and an in-use test if you want "gynecologist tested".
- Regulatory files
EU CPSR, PIF and CPNP notification; US MoCRA listing; other markets as needed.
- Channel review
Check ad and marketplace rules before you shoot content, so images and words pass review.
- Selling a lubricant or vaginal moisturizer as a "cosmetic gel" without device clearance.
- Claiming an intimate wash prevents infections, restores vaginal flora or "balances vaginal pH".
- Using strong fragrance or essential oils in a product for the intimate area.
- Formulating an alkaline, soap-based wash for an area that is naturally acidic.
- Calling a US feminine deodorant spray "hygienic" or leaving out the required caution statement.
- Designing a nozzle or directions that suggest internal use for a cosmetic.
- Planning ads around pleasure or explicit images that ad platforms will reject.
- Each product is classified as cosmetic, device or drug in each market.
- Cosmetic products are for external use only, by formula, pack and directions.
- The wash's pH range is set in the specification and checked every batch.
- Fragrance is absent or very low, and allergens are labeled where required.
- No claims about infections, flora, internal pH, treatment or body function.
- The preservative system passed a challenge test.
- Skin tolerance testing backs every "tested" claim.
- US feminine deodorant sprays carry the 740.12 caution and avoid the word "hygiene".
- Ads and listings follow Meta, Amazon and other platform rules for this category.
- Lubricants and moisturizers are planned with a device manufacturer, not a cosmetic one.
How KoreanOEM helps
KoreanOEM is a Korean skincare OEM and private label manufacturer: our formulation chemists in Busan develop cosmetic formulas, and we produce them in Korea under ISO 22716 (cosmetics GMP). We make cosmetics only.
- Cosmetic intimate care, such as an external intimate wash, is a mild cleanser in cosmetic terms. Our gel and foam cleansers start at 1,000 units with a ready library formula; see private label cleanser. Tell us it is for the intimate area in the quote form, and our team checks the formula, pH, tests and claims with the lab before anything is promised.
- Tests: challenge test from USD 1,000 per formula, patch or low-irritation dermatological test from USD 1,000, HRIPT from USD 3,000 (50 people) or USD 5,500 (100 people). COA and microbiology for every batch.
- Files: MoCRA product listing USD 150 per SKU; EU CPSR and PIF through our partner USD 1,250 per formula; a label proof check before printing.
We do not make medical devices, so we do not make personal lubricants, vaginal moisturizers or other device products.
Frequently asked questions
Is an intimate wash a cosmetic?
Is personal lubricant a cosmetic or a medical device?
What pH should an intimate wash have?
Can an intimate wash claim to prevent yeast infections or BV?
Can I use the word hygiene on a feminine deodorant spray?
Can I advertise intimate care products on Facebook and Instagram?
Does KoreanOEM make lubricants?
Sources
- eCFR: 21 CFR 884.5300 (classification used for personal lubricants, product code NUC)
- FDA: 510(k) K152168 clearance for a personal lubricant (product code NUC, Class II)
- eCFR: 21 CFR 740.12, feminine deodorant sprays
- eCFR: 21 CFR 720.4, cosmetic product categories (douches, feminine hygiene deodorants)
- FDA: Is it a cosmetic, a drug, or both?
- Regulation (EC) No 1223/2009, Article 2 (definition of a cosmetic product)
- EUR-Lex: Regulation (EU) 2017/745 on medical devices
- Meta Transparency Center: Advertising standards, health and wellness (sexual and reproductive health)
- Chen Y, Bruning E, Rubino J, Eder SE. Role of female intimate hygiene in vulvovaginal health. Women's Health, 2017
Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.