FDA Label for Chimborazo Hand Sanitizer
View Indications, Usage & Precautions
Chimborazo Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Chimborazo 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 FDA OTC Hand Sanitizer Monograph. The hand sanitizer is manufactured using only the following ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) and Center for Disease Control (CDC) recommendations:
- 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 (1.00% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile water or boiled cold water.
- Carbomer 940 (<0.5% v/v)
- Tea Tree Oil (0.17% v/v)
- Lavender Oil (0.17% v/v)
- Triethylamine (<0.2% v/v)
- Trace amounts of activated charcoal from filtration of the ethanol
Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria on the skin.
Warnings
For external use only. Flammable. Keep away from heat or flame. Allergy Alert: Contains Tea Tree Oil.
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. 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 10 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, hydrogen peroxide, water, activated charcoal, carbomer 940, denatonium benzoate, tea tree oil
Recent Major Changes
Uses
Hand rub to help reduce bacteria on the skin.
Directions
- Place enough product on hands to cover all surfaces. Rub hands until dry.
- Supervise children under 10 years of age when using this product to avoid swallowing.
Package Label - Principal Display Panel
General Label:
60 mL OR 2 oz. NDC: 80052-001-01:
240 mL OR 8 oz. NDC: 80052-001-02
3785 mL OR 128 oz. NDC: 80052-001-03
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