ACNE VANISHING GEL- 5%- benzoyl peroxide gel

Acne Vanishing Gel- 5% by

Drug Labeling and Warnings

Acne Vanishing Gel- 5% by is a Otc medication manufactured, distributed, or labeled by Only Yourx, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzoyl Peroxide 5%

INACTIVE INGREDIENT

Water, Carbomer, Glycerin, Propylene Glycol, Ethoxydigiycol, Laureth-7, Polyacrylamide C13-14 Isoparaffin, Potassium Sorbate, Triethanolamine, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol

PURPOSE

Acne Medication

INDICATIONS & USAGE

treats acne and helps prevent new acne blemishes from forming

kills acne bacteria

DOSAGE & ADMINISTRATION

Directions:

• Cleanse skin thoroughy before applying
• Cover entire affected area with thin layer 1 to 3 times daily
• If excessive dryness or irritation occurs, reduce application to once a day or every other day
• If going outside, use a sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

WARNINGS

WARNINGS: For External Use Only

OTHER SAFETY INFORMATION

Other Information

• Store at room temperature
• Keep tightly closed

DO NOT USE

Do not use

• If you have very sensitive skin
• If you are sensitive to benzoyl peroxide

WHEN USING

When using this product:

• avoid sun exposure and use sunscreen
• using other acne medications at the same time may cause excessive dryness or irritation of the skin
• may bleach hair and fabrics
• do not use in or near eyes, lips and mouth

ASK DOCTOR

Consult a doctor if excessive irritation occurs

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE VANISHING GEL- 5% 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70367-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LAURETH-7 (UNII: Z95S6G8201)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70367-002-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
2	NDC: 70367-002-04	120 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/26/2014

Labeler - Only Yourx, Inc. (089207519)