REGULAR

US over-the-counter (OTC) label

Brand or trade name

REGULAR

Manufacturer

KAREWAY PRODUCT, INC.

Label date

2 February 2012

Stated use in the United States

Purpose Anticavity

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: aminocaproic acid. 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 15.

Warning: 3 names out of 15 are not recognised ((0.15%, w/v fluoride ion), silicon dioxide, methyl parahydroxybenzoate): nothing below covers them.

• Babies and children : Worth watching SODIUM MONOFLUOROPHOSPHATE

Sodium Monofluorophosphate 0.76%, (0.15%, w/v fluoride ion), calcium carbonate, sorbitol, water, silicon dioxide, glycerine, sodium lauryl sulfate, sodium carboxymethyl cellulose, methyl parahydroxybenzoate, aminocaproic acid, xylitol, sodium saccharin, DL-menthol, flavor

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 SODIUM MONOFLUOROPHOSPHATEAnnex III, entry 27, sets a condition for children: “For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g.”

• Skin, eyes and allergies

  • Worth watching MENTHOLAllergen to declare: Annex III, entry 338, 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.
  • Worth watching AROMA“Parfum” stands for a mixture whose composition does not have to be detailed. Some allergenic substances must nevertheless be named separately in the ingredient list above 0.001% (leave-on product) or 0.01% (rinse-off product). The Regulation names them in 63 entries of its Annex III, for example Linalool, Limonene, Citronellol, Geraniol, Coumarin, Citral, Eugenol or Hexyl Cinnamal: if you are allergic to one of them, look for its name in the list.

• Read on the label

  • For information SODIUM MONOFLUOROPHOSPHATEAnnex III, entry 27, requires this to be printed on the pack: “Contains sodium monofluorophosphate For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory: "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."”.

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), Washington State, California, Japan, 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 2 February 2012 (register: openFDA: US OTC product labels, analysed under European cosmetic rules).

List recorded in 2012. Photograph the packaging to check whether it has changed. Photograph the packaging