Label: ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION- alcohol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 64521-5678-1, 64521-5678-2, 64521-5678-4, 64521-5678-8 - Packager: Sarkli-Repechage, Ltd.
- 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 April 14, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.Directions
• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing. - WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INSTRUCTIONS FOR USE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution
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INGREDIENTS AND APPEARANCE
ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64521-5678 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) WATER (UNII: 059QF0KO0R) HYDROGEN PEROXIDE (UNII: BBX060AN9V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64521-5678-4 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/31/2020 2 NDC:64521-5678-2 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/31/2020 3 NDC:64521-5678-8 236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/14/2020 4 NDC:64521-5678-1 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/31/2020 Labeler - Sarkli-Repechage, Ltd. (012583931) Registrant - Sarkli-Repechage, Ltd. (012583931) Establishment Name Address ID/FEI Business Operations Sarkli-Repechage, Ltd. 012583931 manufacture(64521-5678)