Label: HAND SANITIZER- sanitizer gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76999-7056-3, 76999-7117-6, 76999-7131-5 - Packager: GDRG2, Inc.
- This is a repackaged label.
- Source NDC Code(s): 56084-001, 56084-003, 56084-005
- 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 April 28, 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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SPL UNCLASSIFIED SECTION
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) (73%, 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 (1.00% v/v).
- Carbopol 940 (0.45% v/v).
- Triethanolamine (0.25% v/v).
- Sterile deionized 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
- Uses
- 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
HAND SANITIZER
sanitizer gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76999-7131(NDC:56084-001) Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 40.8 mL in 60 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.6 mL in 60 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.27 mL in 60 mL CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H) 0.15 mL in 60 mL WATER (UNII: 059QF0KO0R) 15.18 mL in 60 mL Product Characteristics Color white (Clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76999-7131-5 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/05/2020 HAND SANITIZER
sanitizer gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76999-7056(NDC:56084-005) Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 170 mL in 250 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 2.5 mL in 250 mL CARBOMER 940 (UNII: 4Q93RCW27E) 1.125 mL in 250 mL CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H) 0.625 mL in 250 mL WATER (UNII: 059QF0KO0R) 63.25 mL in 250 mL Product Characteristics Color white (Clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76999-7056-3 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/05/2020 HAND SANITIZER
sanitizer gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76999-7117(NDC:56084-003) Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 19.72 mL in 29 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.29 mL in 29 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.1305 mL in 29 mL CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H) 0.0725 mL in 29 mL WATER (UNII: 059QF0KO0R) 7.337 mL in 29 mL Product Characteristics Color white (Clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76999-7117-6 29 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/05/2020 Labeler - GDRG2, Inc. (099224092)
