Label: ANTI-BACTERIAL HAND GEL CANDY APPLE- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 59045-1003-1 - Packager: The Man Can, LLC
- 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 July 10, 2013
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
ANTI-BACTERIAL HAND GEL CANDY APPLE
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59045-1003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 60 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) ALOE (UNII: V5VD430YW9) ALOE VERA LEAF (UNII: ZY81Z83H0X) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C RED NO. 4 (UNII: X3W0AM1JLX) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59045-1003-1 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 07/10/2013 Labeler - The Man Can, LLC (063578571)