Calaclear

US over-the-counter (OTC) label

Brand or trade name

Calaclear

Manufacturer

Pharma Nobis, LLC

Barcode

0840986012976

Label date

26 December 2023

Stated use in the United States

Purpose External Analgesic Purpose Skin Protectant

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: Pramoxine HCl 1%. A product that contains it should no longer be sold in the Union. 5 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 14.

Warning: 2 names out of 14 are not recognised (Active Ingredient, Fragrances): nothing below covers them.

Spelling corrected, check it on the packaging: “SD Alcohol 38B 2.5%” read as SD ALCOHOL 38-B.

• Babies and children : Worth watching ZINC ACETATE, Worth watching PROPYLPARABEN

Pramoxine HCl 1%, Active Ingredient, Zinc Acetate, SD Alcohol 38B 2.5% spelling corrected, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water

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

  • Worth watching CAMPHORAllergen to declare: Annex III, entry 331, requires it to be named in the ingredient list above 0.001% in a leave-on product and 0.01% in a rinse-off product, so that allergic people can avoid it.

• 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.

No prohibition or condition found in the recorded lists for: United States (federal), California, 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”.

All US nonprescription labels

List in the official revision dated 26 December 2023 (register: openFDA: US OTC product labels, analysed under European cosmetic rules).

List recorded in 2023. Photograph the packaging to check whether it has changed. Photograph the packaging