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 Gdrg2, Inc.. 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) (73%, 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 (1.00% v/v).
- Carbopol 940 (0.45% v/v).
- Triethanolamine (0.25% v/v).
- Sterile deionized 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)
Ethyl Alcohol 73% v/v. Purpose: Antiseptic
Purpose
Antimicrobial
Uses
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
Flammable. Keep away from heat or flame. For external use only.
Do Not Use
- in or near the eyes
Otc - When Using
When using this product do not use it in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash appears and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Put enough product in palm to cover hands and rub hands together briskley until dry.
- Children under 6 years of age should be supervised when using this product.
Other Information
- Store below 110F (43C)
- May discolor certain fabrics
Inactive Ingredients
Deionized Water, Glycerol, Carbopol 940, Triethanolamine
Package Label - Principal Display Panel
29 mL NDC: 76999-7117-6
60 mL NDC: 76999-7094-5
250 mL NDC: 76999-7056-3
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