OTC Medication Information: Walgreens Acne Spot Treatment

WALGREENS ACNE SPOT TREATMENT- benzoyl peroxide lotion
WALGREEN COMPANY

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 2.5%

Purpose

Acne Medication

Uses

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:

  • 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.
  • 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.

Stop use and ask doctor if

  • irritation becomes severe.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three 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, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

  • Keep tightly closed
  • Avoid storing at extreme temperatures (below 40 F and above 100 F)

Inactive Ingredients

Water, Carbomer, Ethylhexylglycerin, Sodium Hydroxide, Chlorphenesin, Disodium EDTA, Laureth-4, Hydroxypropyl Methylcellulose.

Label

W15121A2
(click image for full-size original)

W15121K1
(click image for full-size original)
WALGREENS ACNE SPOT TREATMENT
benzoyl peroxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0116
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
EDETATE DISODIUM
CHLORPHENESIN
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
LAURETH-4
WATER
SODIUM HYDROXIDE
ETHYLHEXYLGLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0116-51 1 TUBE in 1 CARTON contains a TUBE
1 21 g in 1 TUBE This package is contained within the CARTON (0363-0116-51)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 01/19/2019
Labeler — WALGREEN COMPANY (008965063)

Revised: 01/2023 WALGREEN COMPANY

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.

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