AVERTEAX- zinc oxide and cocoa butter ointment

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
Zinc Oxide (0.015%)     Cold Sores & Fever blisters
Cocoa Butter(0.25%)    Cold Sores & Fever blisters

PURPOSE:

Treatment for 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:

Apply daily as a lip moisturizer and protector for dryness, cold sores, or fever blisters. To achieve best results, apply at the first sign of symptoms (dryness, cracking) directly on the lip and affected area as needed.

OTHER INFORMATION:

During an outbreak, also use AverTeaX Topical Ointment for temporary relief of pain and itching.

STOP USE IF:

Do not use if allergic to any ingredient of the product.

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

INDICATIONS & USAGE:

Indications are for relief of dryness, cold sores and fever blisters.

For relief of dryness, soften cold sores and fever blisters.

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:

Sweet Almond Oil, Grape Seed Oil,  Bees Wax, Shea Butter, Aloe Vera Extract, Royal Jelly, EGCG (Epigallocatechin-3-Gallate, Extracted from Green Tea) Stearate, EGCG Palmitate, Vitamin E, Eucalyptus oil.

PRINCIPAL DISPLAY PANEL

AVERTEAX DAILY LIP PROTECTOR FOR DRYNESS, COLD SORES & FEVER BLISTERS DISTRIBUTED BY CAMELLIX MADE IN USA

Principal display panal

INGREDIENTS AND APPEARANCE

AVERTEAX 
zinc oxide and cocoa butter ointment

Product 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)