Label: HAND SANITIZER GEL- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75660-002-01 - Packager: Solvents and Petroleum Service, Inc.
- 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 June 23, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- Keep OUT OF THE REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER GEL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75660-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.01 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.35 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.18 mL in 100 mL WATER (UNII: 059QF0KO0R) 26.2 mL in 100 mL HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC) 0.25 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75660-002-01 1 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/01/2020 Labeler - Solvents and Petroleum Service, Inc. (013277454) Registrant - Solvents and Petroleum Service, Inc. (013277454) Establishment Name Address ID/FEI Business Operations Clean All 117505240 manufacture(75660-002) , repack(75660-002)
72% Ethyl Alcohol
For external use only. Flammable. Keep away from heat or flame
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.
glycerin, hydrogen peroxide, purified water USP
