Label: ANTI-BACTERIAL HAND GEL- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69358-0006-1 - Packager: UniGroup Wholesale Inc.
- 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 November 12, 2014
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients:Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, FD&C Blue No.1, FD&C Yellow No.5, FD&C Red No.33, FD&C Red No.4.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI-BACTERIAL HAND GEL
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69358-0006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ALOE VERA LEAF (UNII: ZY81Z83H0X) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SUCROSE (UNII: C151H8M554) STARCH, CORN (UNII: O8232NY3SJ) ULTRAMARINE BLUE (UNII: I39WR998BI) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYPROMELLOSES (UNII: 3NXW29V3WO) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69358-0006-1 29 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 11/12/2014 Labeler - UniGroup Wholesale Inc. (079591424)