ELETTE- benzoyl peroxide cream
Stiefel Laboratories Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredient

Benzoyl peroxide 4%

Purpose

Acne medication

Use

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 exosure and use a sunscreen
avoid contact with the eyes, lips, and mouth.
avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product.
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.
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 concentration.

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 right away.

Directions

Wet area to be cleansed.
Apply acne wash and gently massage area for 1-2 minutes.
Rinse thoroughly and pat dry.
Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Other information

Store at room temperature 59°F to 86°F (15°C to 30°C).

Inactive ingredients

cetearyl alcohol, cocamidopropyl betaine, dimethyl isosorbide, glycerin, glycolic acid, hydrogenated castor oil, imidurea, lactic acid, methylparaben, mineral oil, PEG-14M, potassium lauryl sulfate, potassium phosphate, purified water, sodium hydroxide, sodium lauryl sulfate, sodium PCA, titanium dioxide, zea mays (corn) starch.

Questions?

Call 1-888-438-7426. Side effects should be reported to this number.

Principal Display Panel

NDC 0145-2836-46

ELETTE™

creamy wash

benzoyl peroxide, 4%

Lathering creamy cleanser

Hydrates the skin

Gently removes impurities
Clears Blemishes
Reduces Irritation
Defends against future breakouts

: Net Wt 6 oz (170.1 g)
: ELETTE is a trademark of Stiefel Laboratories, Inc.
: Made in Canada
: Rev. 2/12
: Stiefel Laboratories, Inc
: Research Triangle Park, NC 27709
: 10000000103873

ELETTE
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:0145-2836
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (BENZOYL PEROXIDE)	BENZOYL PEROXIDE	58.7 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CETOSTEARYL ALCOHOL
COCAMIDOPROPYL BETAINE
DIMETHYL ISOSORBIDE
GLYCERIN
GLYCOLIC ACID
HYDROGENATED CASTOR OIL
IMIDUREA
LACTIC ACID
METHYLPARABEN
MINERAL OIL
POLYETHYLENE GLYCOL 600000
POTASSIUM LAURYL SULFATE
POTASSIUM PHOSPHATE
WATER
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
SODIUM PYRROLIDONE CARBOXYLATE
TITANIUM DIOXIDE
STARCH, CORN

#	Item Code	Package Description
Packaging
1	NDC:0145-2836-46	1 in 1 CARTON
1		170.1 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	03/18/2012

Labeler - Stiefel Laboratories Inc (808842343)

Name	Address	ID/FEI	Business Operations
Establishment
GlaxoSmithKline Inc		205556368	MANUFACTURE(0145-2836), ANALYSIS(0145-2836), PACK(0145-2836), LABEL(0145-2836)

Revised: 3/2012

Document Id: 1d5d86d5-fa03-4808-b29b-a935b8c068c3

Set id: 1d5d86d5-fa03-4808-b29b-a935b8c068c3

Version: 1

Effective Time: 20120318

Stiefel Laboratories Inc