Label: HAND SANITIZER- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80092-001-01, 80092-001-02, 80092-002-01, 80092-002-02, view more80092-002-03, 80092-003-01, 80092-003-03, 80092-004-04, 80092-005-04 - Packager: MEDENA AG
- 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 August 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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HAND SANITIZER
Alcohol Antiseptic 80%
Topical solution
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:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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)
- Purpose
- Use
- Warnings
- Do not use
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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. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - 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
HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80092-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80092-001-01 100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 08/20/2020 2 NDC:80092-001-02 100 mL in 1 BOTTLE, SPRAY; 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 08/20/2020 HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80092-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 400 mL in 500 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 7.25 mL in 500 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.625 mL in 500 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80092-003-01 500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 08/20/2020 2 NDC:80092-003-03 500 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 08/20/2020 HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80092-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 4000 mL in 5000 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 72.5 mL in 5000 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 6.25 mL in 5000 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80092-004-04 5000 mL in 1 CANISTER; 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 08/20/2020 HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80092-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 8000 mL in 10000 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 145 mL in 10000 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 12.5 mL in 10000 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80092-005-04 10000 mL in 1 CANISTER; 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 08/20/2020 HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80092-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 200 mL in 250 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 3.625 mL in 250 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.3125 mL in 250 mL WATER (UNII: 059QF0KO0R) 46.0625 mL in 250 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80092-002-01 250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 08/20/2020 2 NDC:80092-002-02 250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/20/2020 3 NDC:80092-002-03 250 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 08/20/2020 Labeler - MEDENA AG (480013556)
