OTC Medication Information: Acne Control Cleanser

ACNE CONTROL CLEANSER- benzoyl peroxide cream
Rite Aid

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 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

  • 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.
  • 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 bleaced 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 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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Directions

  • wet face. Gently massage all over face for 20-30 seconds avoiding the eyes. 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 bothersome dryness or peeling occurs, reduce daily application to once a day or every other day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor
  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas, during the first 3 days. If no discomfort occurs, follow the directions stated above.

Other information

  • keep tightly closed
  • store at room temperature (59⁰-77⁰)

Inactive ingredients

water, cetyl alcohol, petrolatum, acrylates/C10-30 alkyl acrylate crosspolymer, zinc lactate, steareth-2, glycerin, potassium cetyl phosphate, xanthan gum, benzyl alcohol, fragrance, disodium EDTA, laureth-4, BHT, sodium hydroxide, lactic acid, menthol

*This product is not manufactured or distributed by the Johnson & Johnson Consumer Products Company, distributor of Clean & Clear Continuous Control Acne Cleanser

Distributed by Rite Aid

principal display panel

daylogic

acne control

cleanser

10% BENZOYL PEROXIDE

ACNE MEDICATION

DAILY CLEANSER

Fights Breakouts After You Wash

COMPARE TO CLEAN & CLEAR

CONTINUOUS CONTROL ACNE CLEANSER

NET WT 5 OZ (141 g)

image description
(click image for full-size original)
ACNE CONTROL CLEANSER
benzoyl peroxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-6184
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 104 mg in 10 g
Inactive Ingredients
Ingredient Name Strength
water
CETYL ALCOHOL
PETROLATUM
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
ZINC LACTATE
STEARETH-2
GLYCERIN
POTASSIUM CETYL PHOSPHATE
XANTHAN GUM
BENZYL ALCOHOL
EDETATE DISODIUM ANHYDROUS
LAURETH-4
BUTYLATED HYDROXYTOLUENE
SODIUM HYDROXIDE
LACTIC ACID
MENTHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-6184-0 141 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 12/07/2017
Labeler — Rite Aid (014578892)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (11822-6184)

Revised: 07/2021 Rite Aid

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.

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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.

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