Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78726-100-10, 78726-100-25, 78726-100-50 - Packager: CANADA GREEN GATE KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI
- 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 5, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient:
- Purpose:
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- Inactive Ingredients:
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78726-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78726-100-10 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/04/2020 2 NDC:78726-100-25 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/04/2020 3 NDC:78726-100-50 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/04/2020 Labeler - CANADA GREEN GATE KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (533123513) Establishment Name Address ID/FEI Business Operations CANADA GREEN GATE KOZMETIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 533123513 manufacture(78726-100)
