Label: HAND SANITIZER- alcohol gel
HAND SANITIZER- ethyl alcohol gel
HAND SANITIZER- alcohol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 77385-028-05, 77385-028-29, 77385-033-76, 77385-034-13, view more77385-057-38, 77385-057-52 - Packager: Camden Passage Inc.
- Category: HUMAN OTC DRUG LABEL
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 May 15, 2020
If you are a healthcare professional or from the pharmaceutical industry 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) (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
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Package Label - Principal Display Panel
70jug.jpg is the 5L 70% alcohol-based sanitizer NDC: 77385-033-76
70pump.jpg is the 500mL 70% alcohol-based sanitizer NDC: 77385-034-13
80jug.jpg is the 5L 80% alcohol-based sanitizer NDC: 77385-057-38
80pump.jpg is the 500 mL 80% alcohol-based sanitizer NDC: 77385-057-52
5L Antiseptic Disinfectant_v01.jpg is the 5L 70% alcohol-based sanitizer NDC 77385-028-05
500mL Antiseptic Disinfectant_v01.jpg is the 500mL 70% alcohol-based sanitizer spray NDC 77385-028-29
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77385-034 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.33 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.4 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) 20 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.35 mL in 100 mL CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.6 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77385-034-13 800 in 1 CASE 12/07/2018 1 20 in 1 CARTON 1 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 12/07/2018 HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77385-033 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.33 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.4 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) 20 mL in 100 mL CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.6 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.35 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77385-033-76 160 in 1 CASE 12/07/2018 1 4 in 1 CARTON 1 5000 mL in 1 JUG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 12/07/2018 HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77385-057 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.8 L in 1 L Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.014 L in 1 L WATER (UNII: 059QF0KO0R) 0.2 L in 1 L HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.00125 L in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77385-057-38 160 in 1 CASE 12/07/2018 1 4 in 1 CARTON 1 5 L in 1 JUG; Type 0: Not a Combination Product 2 NDC:77385-057-52 800 in 1 CASE 12/07/2018 2 20 in 1 CARTON 2 0.5 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 12/07/2018 HAND SANITIZER
alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77385-028 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 30 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77385-028-29 800 in 1 PACKAGE 12/07/2018 1 20 in 1 CARTON 1 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:77385-028-05 160 in 1 PACKAGE 12/07/2018 2 4 in 1 CARTON 2 5000 mL in 1 JUG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 12/07/2018 Labeler - Camden Passage Inc. (250929382) Registrant - Rook Quality Systems (929885247) Establishment Name Address ID/FEI Business Operations Camden Passage Inc. 250929382 manufacture(77385-057, 77385-033, 77385-034, 77385-028)