SPL v2
SPL
SPL Set ID 7e5617ee-d340-422f-bab7-7c1a83419842
Route
TOPICAL
Published
Effective Date 2017-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (2.50 g)
Inactive Ingredients
Water Bentonite Medium-chain Triglycerides Glycerin Polysorbate 20 Glyceryl Laurate Magnesium Aluminum Silicate Xanthan Gum Sodium Citrate Edetate Disodium Anhydrous Citric Acid Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-11-26

Description

Benzoyl peroxide 2.5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl peroxide 2.5%

Uses

Treats and helps prevent new acne blemishes.

Section 51945-4

Warnings

For external use only.

Directions

Cleanse skin thoroughly before applying. COver entire affected area with a thin layer 1 to 3 times daily. Start with one application daily, because excessive drying may occur. 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 outsie use a sunscreen. Allow acne medication to dry before application of sunscreen. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Active Ingredient

Benzoyl peroxide 2.5%

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

Inactive Ingredients

Water, Bentonite, Caprylic/Capric Triglyceride, Glycerin, Emulsifying Wax NF, Polysorbate 20, Glyceryl Laurate, Cetyl Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Sodium Citrate, Disodium EDTA, Citric Acid, Methylparaben, Propylparaben.

Do Not Use If You Have

very sensitive skin or if you are sensitive to benzoyl peroxide.

When Using This Product
  • avoid unnecessary sun exposure and use a sunscreen
  • using other topical acne drugs at the same time or right after use may increase dryness or irritation of skin. If this occurs, only one drug should be used.
  • keep away from eyes, lips, mouth
  • this product may bleach hair or dyed fabrics
Stop Use and Ask A Doctor If

irritation becomes severe and continues.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

Treats and helps prevent new acne blemishes.

Section 51945-4 (51945-4)

Purpose

Acne Treatment

Warnings

For external use only.

Directions

Cleanse skin thoroughly before applying. COver entire affected area with a thin layer 1 to 3 times daily. Start with one application daily, because excessive drying may occur. 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 outsie use a sunscreen. Allow acne medication to dry before application of sunscreen. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Active Ingredient (Active ingredient)

Benzoyl peroxide 2.5%

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

Inactive Ingredients (Inactive ingredients)

Water, Bentonite, Caprylic/Capric Triglyceride, Glycerin, Emulsifying Wax NF, Polysorbate 20, Glyceryl Laurate, Cetyl Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Sodium Citrate, Disodium EDTA, Citric Acid, Methylparaben, Propylparaben.

Do Not Use If You Have (Do not use if you have)

very sensitive skin or if you are sensitive to benzoyl peroxide.

When Using This Product (When using this product)
  • avoid unnecessary sun exposure and use a sunscreen
  • using other topical acne drugs at the same time or right after use may increase dryness or irritation of skin. If this occurs, only one drug should be used.
  • keep away from eyes, lips, mouth
  • this product may bleach hair or dyed fabrics
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation becomes severe and continues.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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