FDA Label for Instant Hand Sanitizer
View Indications, Usage & Precautions
Instant Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Earths Amenities. 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 OTC Monograph Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.
The hand sanitizer is manufactured using
- 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.
- Glycerin
- Aloe Vera Extract
- Water
- Carbomer
- Aminomethyl Propanol
Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
To help reduce bacteria on the skin.
Warnings
For external use only. Flammable. Keep away from fire or flame
Otc - When Using
Do not use on damaged or broken skin. Do not leave near fire. Wash with enough water, if it gets into eyes. Do not drink.
Otc - Stop Use
Stop use and ask a doctor if skin irritation or redness develops.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, get medical help or contact a Poison Control Center right away
Directions
Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times a day.
Other Information
Store below 73.4F (23C)
Inactive Ingredients
Water, glycerin, aloe vera extract, carbomer, aminomethyl propanol
Package Label - Principal Display Panel
60 mL NDC: 74949-001-60
250 mL NDC: 74949-001-25
495 mL NDC: 74949-001-49
1L NDC: 74949-001-01
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