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Acne Med by Face Reality Skin Care, Llc

Medically reviewed on Dec 28, 2017

Dosage form: gel
Ingredients: BENZOYL PEROXIDE 25mg in 1mL
Labeler: Face Reality Skin Care, Llc
NDC Code: 70707-211

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 Med 5%

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

For the treatment of Acne

Also Contains

Purified Water, Glycerin, Propylene Glycol, Carbomer, Sodium Hydroxide.

Uses

Adults and children 12 years and over:

For the treatment of acne.

For acne-prone or oily skin.

Warnings

For external use only. Avoid contact with eyes and eyelids. This product may cause irritation. Mild irritation may be reduced by using the product less frequently. If irritation becomes severe, discontinue use and consult a doctor.

Do not use

this medication if you have very sensitive skin or if you are sensitive to benzoly peroxide.

Keep out of reach of children.

Directions

Apply a thin layer on affected areas. Use for 15 to 30 minutes a day at first and increase wearing time gradually until medication can be tolerated at night. slight irritation is normal and temporary. If going outside, use a sunscreen. Allow the Acne Med to dry, then follow directions in the sunscreen labelling. If irritation or sensitivity develops, discontinue use of product and consult the Clinic.

Other Information

May bleach hair or fabrics. Store at room temperature. Keep away from heat or direct sunlight.

Package Labeling:

ACNE MED 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70707-211
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PROPYLENE GLYCOL 
CARBOXYPOLYMETHYLENE 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:70707-211-0130 mL in 1 TUBE
2NDC:70707-211-0260 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/30/2016
Labeler - Face Reality Skin Care, Llc (602958071)

 
Face Reality Skin Care, Llc

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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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