SINOFRESH KOOLBLAST

US over-the-counter (OTC) label

Brand or trade name

SINOFRESH KOOLBLAST

Manufacturer

ZAPVIR INC.

Label date

12 October 2020

Stated use in the United States

Purpose Oral Antiseptic Uses • Kills germs and bacteria • Reduces germs and bacteria in the mouth and throat

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

2 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. 11 names recognised out of 12.

Warning: 1 name out of 12 is not recognised (Mentha Piperita 3X): nothing below covers it.

Mentha Piperita 3X, Aqua (water), benzalkonium chloride, cetylpyridinium chloride, edetate disodium, eucalyptus oil, glycerin, menthol, polysorbate 80, sorbitol, sucralose, xylitol

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.

• 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.
  • For information BENZALKONIUM CHLORIDEClassified under the CLP Regulation: skin corrosion, category 1B (Skin Corr. 1B). This classification describes the pure substance; in a finished product it is far more diluted.

• Environment

  • Worth watching BENZALKONIUM CHLORIDEClassified under the CLP Regulation: hazardous to the aquatic environment, short term, category 1 (Aquatic Acute 1).

• Read on the label

  • For information BENZALKONIUM CHLORIDEAnnex III, entry 65, requires this to be printed on the pack: “Avoid contact with the eyes”. Annex V, entry 54, requires this to be printed on the pack: “Avoid contact with eyes”.

No official text covers the recognised ingredients for: pregnancy and breastfeeding, babies and children.

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, 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 12 October 2020 (register: openFDA: US OTC product labels, analysed under European cosmetic rules).

List recorded in 2020. Photograph the packaging to check whether it has changed. Photograph the packaging