Label: AVERTEAX- benzyl alcohol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54866-002-01 - Packager: Camellix, LLC
- 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 March 7, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE:
- ASK DOCTOR:
- WARNINGS:
- DIRECTIONS:
- STOP USE:
- INDICATIONS & USAGE:
- DO NOT USE:
- KEEP OUT OF REACH OF CHILDREN:
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INACTIVE INGREDIENT
Ultrez 10 (Carbopol), Cetyl Alcohol (Powder Form), Stearic Acid, E. Glycol Stearate (EGMS), Glyceryl Stearate (GMS), Safflower Oil, Propylene Glycol USP, Glycerin (USP Grade) 99.7%, PMX-200 Silicone Fluid, Euxyl PE 9010 (0.5% - 1.0%), Aloe Vera, EGCG (Epigallocatechin-3-Gallate, Extracted from Green Tea) Stearate, EGCG Palmitate, Eucalyptus oil, Sodium Hyaluronate (Hyaluronic Acid), Lutein 10% (Marigold Ext. 10%), TEA (Triethanolamine)(99%).
- PRINCIPAL DISPLAY PANEL
- Principal display panal
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INGREDIENTS AND APPEARANCE
AVERTEAX
benzyl alcohol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54866-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) CETYL ALCOHOL (UNII: 936JST6JCN) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCOL STEARATE (UNII: 0324G66D0E) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Safflower Oil (UNII: 65UEH262IS) Propylene Glycol (UNII: 6DC9Q167V3) Glycerin (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALOE VERA LEAF (UNII: ZY81Z83H0X) EPIGALLOCATECHIN GALLATE STEARATES (UNII: MGB2NQG22C) EPIGALLOCATECHIN GALLATE PALMITATES (UNII: M213AC47MB) EUCALYPTUS OIL (UNII: 2R04ONI662) Hyaluronic Acid (UNII: S270N0TRQY) LUTEIN (UNII: X72A60C9MT) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54866-002-01 1 in 1 PACKAGE 1 7.4 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(54866-002)