ACNE VANISHING GEL-10%- benzoyl peroxide gel

Acne Vanishing Gel-10% by

Drug Labeling and Warnings

Acne Vanishing Gel-10% by is a Otc medication manufactured, distributed, or labeled by Only Yourx Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

10 % Benzoyl peroxide

PURPOSE

To help with the control of acne

DOSAGE & ADMINISTRATION

• Cleanse skin thoroughly 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 ther day
• If going outside, use a sunscreen

WARNINGS

WARNING: For external use only

INACTIVE INGREDIENT

Water, Glycerin, Propylene Glycol, Ethoxydiglycol, Cetyl Octanoate, Glyceryl, Stearate, PEG-100 Stearate, Cetearyl Alcohol, Ceteareth-20, Dimthicone, Polysorbate 20, Laureth-7, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Polyacrylamide C3-14 Isoparaffin, Potassium Sorbate, Triethanolamine, Disodium EDTA, Ethylhexylglycerin, Phenooxyethanol

INDICATIONS & USAGE

Treats acne and helps prevent new acne blemishes from forming

Kills acne bacteria

KEEP OUT OF REACH OF CHILDREN

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

OTHER SAFETY INFORMATION

Store at room temperature

Keep tightly closed

ASK DOCTOR

Consult a doctor if excessive irritation occurs

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 medicatons at the same time may cause excessive dryness or irritation of the skin
• may bleach hair and fabrics
• do not use near eyes, lips and mouth

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE VANISHING GEL-10% 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70367-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LAURETH-7 (UNII: Z95S6G8201)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70367-001-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
2	NDC: 70367-001-04	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)