ADVANCED ACNE WASH- benzoyl peroxide liquid, extended release

Advanced Acne Wash by

Drug Labeling and Warnings

Advanced Acne Wash by is a Otc medication manufactured, distributed, or labeled by Elorac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Continous Action for Lasting Results

4.4% Benzoyl Peroxide

Dermatologist Developed

ACTIVE INGREDIENT

​Drug Facts

​Active Ingredient

Benzoyl peroxide 4.4%

​Purpose

Acne treatment

​Uses

For the treatment of acne

​Warnings

For external use only

​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.

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.

​Stop use and ask a doctor if

irritation becomes severe

​Keep out of reach of children

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

​Directions

Wet face

Apply to hands then work into a lather and massage gently onto face

Rinse thoroughly and pat dry

Because excessive drying of the skin may occur, start with one application daily, then increase to 2 times daily if needed or as directed by a doctor

If bothersome dryness or peeling occurs, reduce usage to once a day or every other day

If going outside, apply sunscreen after using this product.

If irritation or sensitivity develops, stop use of both products and ask a doctor.

​Other information

THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS

KEEP TIGHTLY CLOSED

Avoid storing at temperatures above 100°F (38°C)

​Inactive ingredients

Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cocamidopropyl Betaine, Ethylhexylglycerin, Euphorbia Cerifera (Candelilla) Wax, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Laureth-7, Phenoxyethanol, Polyacrylamide, Water

Questions?

1-847-362-8200 MON - FRI 9 AM - 5 PM (CST)

​Advanced Acne Wash

Extended - release action for lasting results

Kills bacteria that cause acne

Gentle formula

SPL UNCLASSIFIED SECTION

Manufactured for Elorac, Inc.

Vernon Hills, IL 60061

U.S. Patent No. 6979440

022004 - 2 07/2015 ©2015 Elorac, Inc.

PRINCIPAL DISPLAY PANEL

NDC: 42783-635-04

Elorac, Inc.

Advanced Acne Wash

INGREDIENTS AND APPEARANCE

ADVANCED ACNE WASH 
benzoyl peroxide liquid, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42783-635
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	44 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CANDELILLA WAX (UNII: WL0328HX19)
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42783-635-04	104 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	09/17/2015

Labeler - Elorac, Inc. (832590009)

Registrant - Elorac, Inc. (832590009)