Elette

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 58.7mg in 1g
Labeler: Stiefel Laboratories Inc
NDC Code: 0145-2836

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.
 
©2012 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0145-2836
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE58.7 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:0145-2836-461 TUBE in 1 CARTON
1170.1 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/18/2012
Labeler - Stiefel Laboratories Inc (808842343)
Establishment
NameAddressID/FEIOperations
GlaxoSmithKline Inc205556368MANUFACTURE(0145-2836), ANALYSIS(0145-2836), PACK(0145-2836), LABEL(0145-2836)

Revised: 03/2012
 
Stiefel Laboratories Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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