Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78167-008-01 - Packager: Transformaciones Del Caribe, Sociedad Anonima
- 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 October 10, 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 Sanitizer Gel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78167-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER 934 (UNII: Z135WT9208) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78167-008-01 7570.82 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/02/2020 Labeler - Transformaciones Del Caribe, Sociedad Anonima (817531659) Registrant - Transformaciones Del Caribe, Sociedad Anonima (817531659) Establishment Name Address ID/FEI Business Operations Transformaciones Del Caribe, Sociedad Anonima 817531659 manufacture(78167-008)