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 Charles And Associates, 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
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 (71%, 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).
- Carbomer (8.0% v/v).
- Trolamine (1.0% v/v).
- Sterile distilled water or boiled cold water.
Active Ingredient(S)
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic
Use
Hand Sanitizer to help reduce bacteria on the skin that potentially can cause sickness, recommended for repeated use.
Warnings
For external use only. Flammable. Keep away from heat and flame.
Otc - When Using
Avoid contact with eyes, ears, and mouth. If contact does occur, flush with water.
Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.
Keep out of reach of children. If swallowed, get medical help, or contact poison control center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation and redness develop and presists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help, or contact poison control center right away.
Directions
- Apply a small amount to palms, rubbing briskly to cover both hands until dry - repeat as necessary.
- Supervise children under 6 years with the use of this product. Do not use on infants.
Other Information
- Store at room temperature
- May discolor certain fabrics
- Harmful to wood finishes and plastics
Inactive Ingredients
Deminerialized water, Carbopol 960, Triethanolamine, Glycerin
Package Label - Principal Display Panel
1 gallon / 128 fl oz (3.79 liters) NDC: 78336-070-37
16.9 fl oz (500 ml) NDC: 78336-070-16
8.45 fl oz (250 ml) NDC: 78336-070-08
4.06 fl oz (120 ml) NDC: 78336-070-04
2.03 fl oz (60 ml) NDC: 78336-070-02
1 fl oz (30 ml) NDC: 78336-070-01
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