Label: AVERTEAX- zinc oxide and cocoa butter ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 54866-003-01 - Packager: Camellix, 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 March 8, 2014
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- ACTIVE INGREDIENT
- PURPOSE:
- ASK DOCTOR:
- WARNINGS:
- DIRECTIONS:
- OTHER INFORMATION:
- STOP USE IF:
- INDICATIONS & USAGE:
- DO NOT USE:
- KEEP OUT OF REACH OF CHILDREN:
- INACTIVE INGREDIENT:
- PRINCIPAL DISPLAY PANEL
- Principal display panal
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INGREDIENTS AND APPEARANCE
AVERTEAX
zinc oxide and cocoa butter ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54866-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.15 mg in 1 g COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 2.5 mg in 1 g Inactive Ingredients Ingredient Name Strength ALMOND OIL (UNII: 66YXD4DKO9) GRAPE SEED OIL (UNII: 930MLC8XGG) YELLOW WAX (UNII: 2ZA36H0S2V) SHEA BUTTER (UNII: K49155WL9Y) ALOE VERA LEAF (UNII: ZY81Z83H0X) Royal Jelly (UNII: L497I37F0C) EPIGALLOCATECHIN GALLATE STEARATES (UNII: MGB2NQG22C) EPIGALLOCATECHIN GALLATE PALMITATES (UNII: M213AC47MB) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) EUCALYPTUS OIL (UNII: 2R04ONI662) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54866-003-01 1 in 1 PACKAGE 1 4.2 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2014 Labeler - Camellix, LLC (968429386) Establishment Name Address ID/FEI Business Operations Star Health and Beauty, LLC 013506838 manufacture(54866-003)