Label: HAND SANITIZER ANTICEPTIC- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75887-001-01, 75887-001-02, 75887-001-03, 75887-001-04, view more75887-001-05 - Packager: Aztex Enterprises
- 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 December 21, 2018
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- Official Label (Printer Friendly)
- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER ANTICEPTIC
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75887-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 5 mL in 8 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER 1342 (UNII: 809Y72KV36) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color Score Shape Size Flavor LEMON (Lemon Fragrance) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75887-001-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/13/2011 2 NDC:75887-001-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/13/2011 3 NDC:75887-001-03 8 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/13/2011 4 NDC:75887-001-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/13/2011 5 NDC:75887-001-05 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/13/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/13/2011 Labeler - Aztex Enterprises (253232326) Registrant - Aztex Enterprises (253232326) Establishment Name Address ID/FEI Business Operations Aztex Enterprises 253232326 manufacture(75887-001)