Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78153-000-08, 78153-000-13, 78153-000-19 - Packager: Quimi Clean
- 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 May 26, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
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Warnings
For external use only: hands
Flammable, keep away from fire or flame
When using this product
keep out of eyes, In case of contact with eyes, flush thoroughly with water./ avoid contact with broken skin/ do not inhale or ingest.
- Directions
- Other Information
- Inactive Ingredients
- Package Labeling:240ml
- Package Labeling:400ml
- Package Labeling:580ml
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78153-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLOYL/CAPROYL METHYL GLUCAMIDE (UNII: 0451R360HR) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78153-000-08 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 2 NDC:78153-000-13 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 3 NDC:78153-000-19 580 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/15/2020 Labeler - Quimi Clean (951578018) Establishment Name Address ID/FEI Business Operations Quimi Clean 951578018 manufacture(78153-000)