Label: CHIMBORAZO HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80052-001-01, 80052-001-02, 80052-001-03 - Packager: Chimborazo LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 16, 2020
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
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)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
CHIMBORAZO HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80052-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.000005 mL in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL in 1 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.004 mL in 1 mL LAVENDER OIL (UNII: ZBP1YXW0H8) 0.0017 mL in 1 mL TEA TREE OIL (UNII: VIF565UC2G) 0.0017 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.2742 mL in 1 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.005 mL in 1 mL TRIETHYLAMINE (UNII: VOU728O6AY) 0.002 mL in 1 mL ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) 0.0001 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80052-001-01 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/20/2020 2 NDC:80052-001-02 240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/20/2020 3 NDC:80052-001-03 3786 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/11/2020 Labeler - Chimborazo LLC (130532330) Registrant - Chimborazo LLC (130532330) Establishment Name Address ID/FEI Business Operations Chimborazo LLC 130532330 manufacture(80052-001) , label(80052-001)
