OTC Medication Information: Acne Treatment

ACNE TREATMENT- benzoyl peroxide cream
CVS

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.

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne treatment

Uses

For the treatment of acne.

Warnings

For external use only.

Do not use

  • if you have very sensitive skin or are sensitive to Benzoyl Peroxide

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.
  • rinse right away with water if it gets in eyes.
  • avoid unnecessary sun exposure and use a sunscreen.
  • avoid contact with 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, possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop 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

  • cleanse the skin thoroughly before applying medication
  • cover the entire affected area with a thin layer one to three times a day
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • if going outside, use a sunscreen. Allow product to dry then follow directions in the sunscreen labeling. if sensitivity develops, discontinue use of both products and consult a doctor.

Inactive ingredients

Aluminum hydroxide, Bentonite, Carbomer, Glyceryl Stearate SE, Isopropyl myristate, Methylparaben, PEG-12, Potassium Hydroxide, Propylene Glycol, Propylparaben, Water

image description
(click image for full-size original)
image description
(click image for full-size original)

ACNE TREATMENT
benzoyl peroxide 10% cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-240
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE
BENTONITE
GLYCERYL STEARATE SE
ISOPROPYL MYRISTATE
METHYLPARABEN
POLYETHYLENE GLYCOL 600
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-240-01 28 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 10/31/2014
Labeler — CVS (062312574)
Registrant — Product Quest Mfg, LLC (927768135)
Establishment
Name Address ID/FEI Operations
Product Quest Mfg, LLC 927768135 manufacture (59779-240), label (59779-240)

Revised: 12/2017 CVS

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.