PRO-SYS
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
- PRO-SYS
- Manufacturer
- Forward Science Technologies LLC
- Barcode
- 0370275937166
- Label date
- 30 July 2026
Stated use in the United States
Purpose Oral Debriding Agent / Oral Wound Cleanser
Published active ingredients
Hydrogen Peroxide 1.5% (w/v)
Published inactive ingredients
Methyl Salicylate, PEG-40, Propylene Glycol, Water, Xylitol
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
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. 6 names recognised out of 6.
- Pregnancy and breastfeeding : Worth watching METHYL SALICYLATE
- Babies and children : Prohibition or serious classification METHYL SALICYLATE, Worth watching HYDROGEN PEROXIDE
Hydrogen Peroxide 1.5%, Methyl Salicylate, PEG-40, Propylene Glycol, Water, 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.
Pregnancy and breastfeeding
- Worth watching METHYL SALICYLATEClassified under the CLP Regulation: reproductive toxicity, category 2 (Repr. 2), a hazard to the unborn child. The European Union nevertheless allows it under the conditions of its annex, after an opinion of its Scientific Committee on Consumer Safety (SCCS).
Babies and children
- Prohibition or serious classification METHYL SALICYLATEAnnex III, entry 324, prohibits it in products intended for children under 6: “Not to be used in preparations for children under 6 years of age, with the exception of (k) “Toothpaste”.”
- Worth watching HYDROGEN PEROXIDEAnnex III, entry 12, prohibits it for children under 18 in certain products only: “Not to be used on a person under 18 years of age.”
Skin, eyes and allergies
- Worth watching METHYL SALICYLATEClassified under the CLP Regulation: skin sensitisation, category 1B (Skin Sens. 1B). Allergen to declare: Annex III, entry 324, 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 HYDROGEN PEROXIDEClassified under the CLP Regulation: skin corrosion, category 1A (Skin Corr. 1A). This classification describes the pure substance; in a finished product it is far more diluted.
Environment
- For information METHYL SALICYLATEClassified under the CLP Regulation: hazardous to the aquatic environment, long term, category 3 (Aquatic Chronic 3).
Read on the label
- For information HYDROGEN PEROXIDEAnnex III, entry 12, requires this to be printed on the pack: “(a) (f) Wear suitable gloves (a) (b) (c) (e) Contains hydrogen peroxide Avoid contact with eyes Rinse immediately if product comes into contact with them. (e) Concentration of H2O2 present or released indicated in percentage. Not to be used on a person under 18 years of age. To be only sold to dental practitioners. For each cycle of use, the first use to be only done by dental practitioners or under their direct supervision if an equivalent level of safety is ensured. Afterwards to be provided to the consumer to complete the cycle of use. f) To be printed on the label: ‘For professional use…”.
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 | - | - | Hydrogen Peroxide 1.5%, Methyl Salicylate |
| Canada | - | - | Hydrogen Peroxide 1.5%, Methyl Salicylate |
| Japan | Hydrogen Peroxide 1.5% | - | - |
| South Korea | - | - | Hydrogen Peroxide 1.5% |
| Australia | - | Hydrogen Peroxide 1.5% | - |
| ASEAN | - | - | Hydrogen Peroxide 1.5% |
| Taiwan | Hydrogen Peroxide 1.5% | - | Methyl Salicylate |
No prohibition or condition found in the recorded lists for: United States (federal), Washington State, California, China, Brazil.
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) |
|---|---|---|---|
| Hydrogen Peroxide 1.5% | HYDROGEN PEROXIDE | Allowed with restrictions (Annex III) Annex III, entry 12: products: (a) Hair products (b) Skin products (c) Nail hardening products (d) Oral products, including mouth rinse, tooth paste and tooth whitening or bleaching products (e) Tooth whitening or bleaching products (f) Products intended for eyelashes; maximum concentration: (a) 12% of H2O2 (40 volumes), present or released (b) 4% of H2O2, present or released (c) 2% of H2O2, present or released (d) ≤ 0.1% of H2O2, present or released (e) > 0.1% ≤ 6% of H2O2, present or released (f) 2% of H2O2, present or released | none |
| Methyl Salicylate | METHYL SALICYLATE | Allowed with restrictions (Annex III) Annex III, entry 324: products: (a) Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic-based fragrances) and leave on hair products (except spray/aerosol products) (b) Face makeup (except lip products, eye makeup and makeup remover) (c) Eye makeup and makeup remover (d) Leave-on hair products (spray/aerosol) (e) Deodorant spray/aerosol (f) Body lotion spray/aerosol (g) Rinse-off skin products (except hand wash) and rinse-off hair products (h) Hand wash (i) Hydroalcoholic-based fragrances (j) Lip products (k) Toothpaste (l) Mouthwash intended for children aged 6–10 years (m) Mouthwash intended for children above 10 years of age and adults (n) Mouth spray; maximum concentration: (a) 0.06% (b) 0.05% (c) 0.002% (d) 0.009% (e) 0.003% (f) 0.04% (g) 0.06% (h) 0.6% (i) 0.6% (j) 0.03% (k) 2.52% (l) 0.1% (m) 0.6% (n) 0.65% | Toxic for reproduction: suspected effect (category 2, CLP classification) |
| PEG-40 | PEG-40 | 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 |
| Xylitol | XYLITOL | 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.