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Acne Treatment by I. Shay Cosmetics

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 0.026mg in 1mg
Labeler: I. Shay Cosmetics
NDC Code: 65112-205

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.

Acne Treatment

Benzoyl Peroxide 2.6% ... Acne Treatment

Acne Treatment

WARNINGs - Keep out of reach of children.

For the treatment of acne.

Purified Water, Propylene Glycol, Carbomer, Glycerin,
PEG 400, Phenoxyethanol, Sodium Hydroxide,
Methylparaben, Lavender Fragrance


For external use only.

When using 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.

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 the 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 concentration.
Stop use & ask a doctor if irritation becomes severe.


clean the skin thoroughly before applying this product


acne treatment cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65112-205
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
WATER0.9 mg  in 1 mg
#Item CodePackage Description
1NDC:65112-205-01118 mg in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/13/2015
Labeler - I. Shay Cosmetics (151582384)

Revised: 06/2016
I. Shay Cosmetics

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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.