AVERTEAX- benzyl alcohol cream

AVERTEAX by

Drug Labeling and Warnings

AVERTEAX by is a Otc medication manufactured, distributed, or labeled by Camellix, LLC, Star Health and Beauty, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient        Purpose
 Benzyl Alcohol (1.0%)     Cold Sores & Fever blisters

PURPOSE:

Treats cold sores and fever blisters, a vesicle that occurs at the junction of the mucous membrane and the skin on the lips or nose and is caused by the virus herpes simplex, type 1.

ASK DOCTOR:

If condition worsens or does not improve after regular use of the product as directed, consult a doctor.

If swallowed, contact a doctor.

WARNINGS:

For external use only.

DIRECTIONS:

For the temporary relief of pain and itching of cold sores and fever blisters, apply AverTeaX ointment directly on the affected area throughout the day as needed. To achieve best result, apply at the frist sign of symptons (redness, tingling, tightness, or itching.)

STOP USE:

If illergic to any ingridient of the product.

INDICATIONS & USAGE:

Indications are for pain and itching associated with fever blisters and cold sores.

For the temporary Relief of Pain and itching associated with fever blisters and cold sores.

DO NOT USE:

If allergic to any ingredient of the product.

KEEP OUT OF REACH OF CHILDREN:

• Keep out of reach of children.
• If swallowed, contact a doctor. 

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

AVERTEAX TOPICAL OINTMENT COLD SORES AND FEVER BLISTERS TREATMENT DISTRIBUTED BY CAMELLIX MADE IN USA

Principal display panal

INGREDIENTS AND APPEARANCE

AVERTEAX 
benzyl alcohol cream

Product 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)