Label: CANDY APPLE- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58194-012-01 - Packager: Shanghai Weierya Daily Chemicals Factory
- 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 June 4, 2014
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- Official Label (Printer Friendly)
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CANDY APPLE
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58194-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 65 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor APPLE (candy apple) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58194-012-01 29 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/01/2014 Labeler - Shanghai Weierya Daily Chemicals Factory (420359333) Establishment Name Address ID/FEI Business Operations Shanghai Weierya Daily Chemicals Factory 420359333 manufacture(58194-012)