ACNE VANISHING GEL- 10% WITH SULFUR- benzoyl peroxide, sulfur gel

Acne Vanishing Gel- 10% with Sulfur by

Drug Labeling and Warnings

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

Drug Details [pdf]

WARNINGS

WARNINGS: For External Use Only

ACTIVE INGREDIENT

Active Ingredients:

Benzoyl Peroxide 10%

Sulfur 3%

INDICATIONS & USAGE

Treats acne and helps prevent new blemishes from forming

Kills acne bacteria

DO NOT USE

Do Not Use: if you have very sensitive skin

are sensitive to benzoyl peroxide or sulfur

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions:

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 oter day
if going outside, use a sunscreen

OTHER SAFETY INFORMATION

Other information

store at room temperature

keep tightly closed

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Ethoxydiglycol, Cetyl Octanoate, Glyceryl Stearate, APEG-100 Stearate, Glycerin, Propylene Glycol, Cetearyl Alcohol, Ceteareth-20, Polyacrylamide C13-14 Isoparaffin, Laureth-7, Dimethicone, Potassium Sorbate, Polysorbate 20, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Triethanolamine, Ethylhexylglycerin, Phenoxyethanol

PURPOSE

To treat acne and reduce inflammation

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE VANISHING GEL- 10% WITH SULFUR 
benzoyl peroxide, sulfur gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70367-003
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
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETEARETH-22 (UNII: 28VZG1E234)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL OCTACOSANOATE (UNII: O7F4812VDX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
LAURETH-7 (UNII: Z95S6G8201)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70367-003-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	08/26/2014
2	NDC: 70367-003-04	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	03/28/2014

Labeler - Only Yourx, Inc. (089207519)