FDA Label for Hand Sanitizer Alcohol Antiseptic 70% Topical Gel
View Indications, Usage & Precautions
Hand Sanitizer Alcohol Antiseptic 70% Topical Gel Product Label
The following document was submitted to the FDA by the labeler of this product Solugen Blending Llc. 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 part333A of the OTC Monograph.
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).
- 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 (1.5% v/v).
- Hydroxymethyl Cellulose (1.3% v/v).
- Sterile distilled water or boiled cold water.
Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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 occurs. These may be signs of a serious condition.
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
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
glycerin, methylcellulose, purified water USP
Hand Sanitizer Alcohol Antiseptic 70% Topical Gel
18927000 mL NDC: 79975-003-01
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