Label: HAND SANITIZER- antiseptic liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78797-014-01 - Packager: GRUPO PIRRETEAM SA DE CV
- 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 August 31, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Uses
- Active Ingredient
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Warnings
- For external use only
- When using this product avoid contact with eyes. In case of contact, flush with water for several minutes.
- Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
- Stop use and ask Doctor: if skin irritation develops when using this product
- Flammable: Keep away from heat and flame. Highly flammable liquid and vapor/
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive Ingredients
- Questions?
- Uses
- Hand Soap
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
antiseptic liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78797-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 1 mg in 1 mL ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE SODIUM (UNII: MP1J8420LU) POLIDOCANOL (UNII: 0AWH8BFG9A) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) COCO DIETHANOLAMIDE (UNII: 92005F972D) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78797-014-01 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/09/2020 Labeler - GRUPO PIRRETEAM SA DE CV (951579014) Registrant - GRUPO PIRRETEAM SA DE CV (951579014) Establishment Name Address ID/FEI Business Operations GRUPO PIRRETEAM SA DE CV 817531659 label(78797-014) Establishment Name Address ID/FEI Business Operations KUII PRODUCTOS DE LIMPIEZA SA DE CV 951578840 manufacture(78797-014)