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Acne Treatment by I. Shay Cosmetics

Medically reviewed on June 11, 2018

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

WARNINGS

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.

DIRECTIONS

clean the skin thoroughly before applying this product

5

ACNE TREATMENT 
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
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE0.026 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
WATER0.9 mg  in 1 mg
Packaging
#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)

 
I. Shay Cosmetics

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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