FDA Label for Hand Sanitizer
View Indications, Usage & Precautions
Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Tu Negocio En Minutos Sa De Cv. 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.
Other
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 World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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 (1.45% v/v).
- TRIETHANOLAMINE BENZOATE (0.125% v/v).
- Carbomer 940 0.5%
- Sterile distilled water or boiled cold 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%. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
To decrease bacteria on the skin that could cause disease, Recommended for repeated use
Warnings
For external use only: hands Do not drink Flammable. Keep away from heat and flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
Keep out of eyes in case of contact with eyes, flush thoroughly with water, Avoid contact with broken skin,
Do not inhale or ingest.
Otc - Stop Use
Skin irritation develops.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center Right away.
Directions
Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.
Other Information
Do not store above105oF, may discolor some fabrics, Harmful to wood finishes and plastics.
Inactive Ingredients
Purified Water, Glycerin, Triethanolamine, Carbomer.
Package Label - Principal Display Panel
1000 mL NDC: 79219-001-02
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