FDA Label for Instant Unscented Hand Sanitizer With Aloe Vera Advanced
View Indications, Usage & Precautions
Instant Unscented Hand Sanitizer With Aloe Vera Advanced 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
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.
- Glycerin
- Aloe Vera Extract
- Water
- Caprylyl Glycol
- Decylene Glycol
- Benzoic Acid
- Carbomer
- Triethanolamine
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 70% v/v. Purpose: Antiseptic
Uses
Antiseptic
Warnings
For external use only. Flammable. Keep away from fire or flame
Otc - When Using
When using this product 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
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, aloe barbadensis (aloe vera extract), triethanolamine, glycerin, caprylyl glycol, decylene glycol, benzoic acid, carbomer
Indications & Usage
To help reduce bacteria on the skin
Package Label - Principal Display Panel
60 mL NDC: 74949-002-60
250 mL NDC: 74949-002-25
495 mL NDC: 74949-002-49
20000 mL NDC: 74949-002-20
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