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 Sell-able 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 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:
- Isopropyl Alcohol (75%, 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).
- Hydrogen peroxide (0.125% v/v).
- 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)
BENZALKONIUM CHLORIDE .12 g/100mL
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. Helps to prevent cross-contamination
Warnings
For external use only.
When Using This Product
- Do not use in or near eyes
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develop.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Other Information
- Store in a cool dry place below 104 degress F (40C)
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLOXAMER 124 (UNII: 1S66E28KXA)
D&C GREEN NO. 8 (UNII: I2W85YOX9L)
Directions
- Receive a small amount of foam into palm of hand.
- Rub thoroughly over all surfaces of both hands
- Rub hands together until dry.
* Please review the disclaimer below.