ACNE TREATMENT- benzoyl peroxide lotion

Acne Treatment by

Drug Labeling and Warnings

Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Vivier Pharma, Inc., Dermolab Pharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SkinTx Acne Treatment Lotion Benzoyl Peroxide Lotion USP 5%

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Treatment

Use

For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and whiteheads.

Warnings

For external use only

Ask a doctor before use if you are

• using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.  If this occurs, only one medication should be used unless directed by a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use if you

• have very sensitive skin.
• are sensitive to Benzoyl Peroxide.

When using this product

• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with eyes, lips, and mouth
• avoid contact with hair and dyed fabrics, which may be bleached by this product 
  
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower oncentration.
  

Stop use and ask a doctor if

• irritation becomes severe.

Directions

• Wash hands with a non-medicated soap (contains no Benzoyl Peroxide).
• Cleanse and dry face thoroughly 5 minutes before use.
• Using fingertips apply evenly to affected areas.
  
• Use both morning and night or as directed by a physician.
• If dryness or peeling occurs, reduce application to once a day or every other day.
  
• Fair- skinned individuals should begin with one application.
  
• For more severe cases, and/or if substantial improvement is not apparent within 3 to 4 weeks, consult a health care practitioner.

Inactive Ingredients

C13-14 Isoparaffin, Ethylhexylglycerin, Lanolin Oil, Laureth-4, Laureth-7, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Water/Eau, Xanthan Gum.

Other Information

•  store at room temperature (59-86°F / 15-30°C)

SkinTx Acne Treatment Lotion Benzoyl Peroxide Lotion USP 5%

INGREDIENTS AND APPEARANCE

ACNE TREATMENT 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67226-2050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LANOLIN OIL (UNII: OVV5IIJ58F)
LAURETH-4 (UNII: 6HQ855798J)
LAURETH-7 (UNII: Z95S6G8201)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67226-2050-3	1 in 1 BOX	11/01/2011
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/01/2011

Labeler - Vivier Pharma, Inc. (250996550)

Establishment
Name	Address	ID/FEI	Business Operations
Dermolab Pharma Ltd		245414743	manufacture(67226-2050)