FDA Label for Disinfex
View Indications, Usage & Precautions
Disinfex Product Label
The following document was submitted to the FDA by the labeler of this product Rk Kozmetik Ve Hijyen Urunleri Sanayi Dis Ticaret Anonim Sirketi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (0.5% v/v).
- Aloe Vera Leaf (0.1% v/v).
- Carbomer 940 (0.3% v/v).
- Aminomethylpropanol (0.15% v/v).
- Sterile distilled water
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Disinfex Hand Sanitizer
Uses
to help reduce bacteria on the skin. For use when soap and water are not avaliable.
Warnings
For external use only. Flammable liquid and vapor. Keep away from heat/sparks/open flame. No smoking. Avoid sprayin in eyes.
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness devolops and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a poison Control Center immediately.
Directions
- Put enough product in your palm to cover hands and rub hands together until dry.
- Children under 6 years should be supervised when using this product.
Other Information
- Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F)
- may discolor certain fabrics or surfaces.
Inactive Ingredients
Water (Aqua), Glycerin, Aloe Barbadensis Leaf Juice, Carbomer, Aminomethylpropanol.
Package Label - Principal Display Panel
50 mL NDC: 79320-120-01
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