ANTI-ITCH
US over-the-counter (OTC) label
Aux États-Unis, ces produits sont vendus comme médicaments en vente libre (OTC) : solaires, antitranspirants, antipelliculaires, dentifrices anticaries, produits contre l'acné ou protecteurs cutanés. L'étiquette distingue les ingrédients actifs et inactifs. Dans l'Union européenne, un produit à finalité cosmétique doit respecter le règlement (CE) n° 1223/2009. Un filtre ou un actif admis aux États-Unis peut ne pas être autorisé pour cet usage dans l'Union. La qualification dépend de la finalité : un désinfectant pour les mains peut relever des biocides et un traitement de l'acné des médicaments. Cette analyse applique les règles cosmétiques aux ingrédients, sans établir la conformité du produit fini. La formule vendue en Europe sous le même nom peut être différente.
openFDA: US OTC product labels, analysed under European cosmetic rules, retrieved 28 October 2026.
- Brand or trade name
- ANTI-ITCH
- Manufacturer
- OL PHARMA TECH, LLC
- Label date
- 9 January 2025
Stated use in the United States
Purpose Topical analgesic skin protectant
Published active ingredients
Diphenhydramine hydrochloride 1% Zinc Acetate 0.1%
Published inactive ingredients
cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E
openFDA: US OTC product labels, analysed under European cosmetic rules, retrieved 28 October 2026.
Label in the official openFDA API. This is the label date; the formula may have changed. Compare with the packaging.
Cosmetic analysis in the European Union
1 ingredient prohibited in cosmetics in the European Union: Diphenhydramine hydrochloride 1%. A product that contains it should no longer be sold in the Union. 3 ingredients allowed under conditions (maximum concentration, product types): some active ingredient concentrations are printed; the other conditions and the product's classification in the European Union remain to be checked. 12 names recognised out of 13.
Warning: 1 name out of 13 is not recognised (sodium cetostearyl sulfate): nothing below covers it.
- Babies and children : Worth watching ZINC ACETATE, Worth watching PROPYLPARABEN
Diphenhydramine hydrochloride 1%, Zinc Acetate 0.1%, cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil, propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E
Who it concerns
For each group, the ingredients of the list that an official classification or rule mentions. Open an ingredient's page to read what the text says. A group with no name does not mean the ingredients were judged to have no effect for it.
Prohibition or serious classificationThe text prohibits the substance for this use, or ranks it among the most serious hazards (known or presumed carcinogenic, mutagenic or reprotoxic, identified endocrine disruptor).Worth watchingThe text sets a condition or flags a hazard worth knowing: allergen, suspected effect, condition for children, hazard to the aquatic environment.For informationOfficial information with no condition on a finished product: warning to read, irritation of the pure substance.
Babies and children
- Worth watching ZINC ACETATEAnnex III, entry 24, sets a condition for children, for these products only: (b) Toothpaste intended for children between 6 months and 1 year of age. “(b) Toothpaste intended for children between 6 months and 1 year of age”
- Worth watching PROPYLPARABENAnnex V, entry 12 a, prohibits it for children under 3 in certain products only: “Not to be used in leave-on products designed for application on the nappy area of children under three years of age.”
Skin, eyes and allergies
- For information EDTAClassified under the CLP Regulation: eye irritation, category 2 (Eye Irrit. 2). This classification describes the pure substance; in a finished product it is far more diluted.
Read on the label
- For information PROPYLPARABENAnnex V, entry 12 a, requires this to be printed on the pack: “For leave-on products designed for children under three years of age: "Do not use on the nappy area"”.
No official text covers the recognised ingredients for: pregnancy and breastfeeding, environment.
For a question about your own situation (pregnancy, child, allergy), show this list to your doctor, midwife or pharmacist: we cannot say whether this product suits you.
Selling elsewhere
Ingredients of this list that are prohibited, prohibited in some cases or subject to conditions in the other countries whose rules we record (nothing changes for sale in France). Absence is not approval: several countries only allow the preservatives, UV filters and colorants on their lists, and the function of an ingredient in the product is not known. What is covered for each country.
| Country | Prohibited | Prohibited in some cases | Subject to conditions |
|---|---|---|---|
| United Kingdom | Diphenhydramine hydrochloride 1% | - | Zinc Acetate 0.1%, methyl paraben, propyl paraben |
| South Korea | - | - | Zinc Acetate 0.1%, methyl paraben, propyl paraben, vitamin E |
| ASEAN | Diphenhydramine hydrochloride 1% | - | methyl paraben, propyl paraben |
| Taiwan | - | - | methyl paraben, propyl paraben |
| Brazil | Diphenhydramine hydrochloride 1% | - | methyl paraben, propyl paraben |
No prohibition or condition found in the recorded lists for: United States (federal), Washington State, California, Canada, Japan, China, Australia.
Ingredient by ingredient
The line under each name gives its rule in the European Union (legend below). Click a name for its page.
Hover over or tap a badge for its meaning.
Classified hazard (cancer, DNA, reproduction): Carcinogenic, mutagenic or toxic for reproduction under the CLPEU regulation that classifies chemicals by their hazards (EC No 1272/2008). Regulation, or identified endocrine disruptor. Irritation, allergy and environment: see “Who it concerns”.
| On the label | Glossary name | Rule in the European Union | Classified hazard (cancer, DNA, reproduction) |
|---|---|---|---|
| Diphenhydramine hydrochloride 1% | DIPHENHYDRAMINE HCl Certainty certain: checked synonym | Prohibited in cosmetics (Annex II) | none |
| Zinc Acetate 0.1% | ZINC ACETATE | Allowed with restrictions (Annex III) Annex III, entry 24: products: (a) Toothpaste intended for users above 1 year of age (b) Toothpaste intended for children between 6 months and 1 year of age (c) Mouthwash intended for users above 6 years of age (d) Other products; maximum concentration: (a) 1% (as zinc) (b) 0.72% (as zinc) (c) 0.1% (as zinc) (d) 1% (as zinc) | none |
| cetostearyl alcohol | CETEARYL ALCOHOL Certainty certain: checked synonym | No specific rule in the Cosmetics Regulation | none |
| sodium cetostearyl sulfate | not recognised | Name not recognised in the European glossary | unknown |
| stearic acid | STEARIC ACID | No specific rule in the Cosmetics Regulation | none |
| trolamine | TRIETHANOLAMINE Certainty certain: checked synonym | Cited as an example in a rule, no rule of its own (Annex III) | none |
| mineral oil | MINERAL OIL | No specific rule in the Cosmetics Regulation | none |
| propylene glycol | PROPYLENE GLYCOL | No specific rule in the Cosmetics Regulation | none |
| water | WATER | No specific rule in the Cosmetics Regulation | none |
| methyl paraben | METHYLPARABEN Certainty high: same name, spelling aside | Preservative allowed under conditions (Annex V) Annex V, entry 12: maximum concentration: 0.4% (as acid) for single ester 0.8% (as acid) for mixtures of esters | none |
| propyl paraben | PROPYLPARABEN Certainty high: same name, spelling aside | Preservative allowed under conditions (Annex V) Annex V, entry 12 a: maximum concentration: - 0.14% (as acid) for the sum of the individual concentrations - 0.8% (as acid) for mixtures of substances mentioned in entry 12 and 12a, here the sum of the individual concentrations of butyl and propylparaben and their salts does not exceed 0.14% | none |
| EDTA | EDTA | No specific rule in the Cosmetics Regulation | none |
| vitamin E | TOCOPHEROL Certainty high: verified official synonym, high confidence match | No specific rule in the Cosmetics Regulation | none |
List in the official revision dated (register: openFDA: US OTC product labels, analysed under European cosmetic rules).
Has the product changed? Photograph the packaging.