Acne Therapy Lotion

Acne Therapy Lotion
SPL v2
SPL
SPL Set ID 4dec259d-200e-44f2-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (30 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Urea Butylene Glycol Cyclomethicone 5 Magnesium Aluminum Silicate Steareth-20 Peg-100 Stearate Starch, Corn Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Squalane Polysorbate 60 Matricaria Chamomilla Camellia Oleifera Leaf Lecithin, Soybean Vitamin A Palmitate Tocopherol Ascorbyl Palmitate .beta.-carotene Ethylhexylglycerin Cetostearyl Alcohol Glycerin Caprylyl Glycol Dimethicone Steareth-2 Propylene Glycol Panthenol Edetate Disodium Anhydrous Allantoin Phytonadione

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-04-20

Description

Benzoyl Peroxide 3%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 3%

​uses

for the treatment and prevention of acne

Drug Facts

​purpose

Acne Treatment

Do Not Use:

If you have very sensitive skin or sensitive to benzoyl peroxide.

​warnings

​For external use only.

​directions:

Shake before using.  Apply to clean skin.  Cover the affected area with a thin layer 1 to 3 times daily.  Because too much drying of the skin may occur, start with 1 application daily or every other day, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.  If bothersome dryness or peeling occurs, reduce applicaction once a day or every other day.  If going outside, allow product to dry, then use a sunscreen.  Store at 20-25 ​C (68-77 ​F) ​o ​o

Package Labeling:

​active Ingredient

Benzoyl Peroxide 3%

​inactive Ingredients

Aqua purificata (purified water), C12-15 Alkyl Benzoate, Urea, Butylene Glycol, Cyclopentasiloxane, Magnesium aluminum silicated, Steareth-20, Peg-100 stearate, Zea mays (corn) starch, Hydroxyethyl acrylate/sodium acryloydimethyl, Taurate copolymer, Squalane, Polysorbate 60, Chamomilla recutita (matricaria) extract, Camellia oleifera leaf extract, Phospholipids, Retinyl palmitate, Tocopherol, Ascorbyl palmitate, Beta-carotene, Ethylhexylglycerin, Cetearyl alcohol, Glycerin, Caprylyl glycol, Dimethicone, Acrylates/C10-30 alkyl acrylate crosspolymer, Steareth-2, Butylene Glycol, Propylene glycol, Panthenol, Disodium EDTA, Allantoin, Phytonadione.

​when Using This Product:

Apply to affected areas only.  Avoid unnecessary sun exposure and use a sunscreen.  Do not use in or near the eyes, lips or mouth.  This product may bleach hair or dyed fabrics.  Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a poison control center right away.

Discontinue Use and Ask A Doctor

 if skin irritation becomes severe or if you are using more than one acne medication.


Structured Label Content

​uses (​Uses)

for the treatment and prevention of acne

Drug Facts

​purpose (​Purpose)

Acne Treatment

Do Not Use: (Do not use:)

If you have very sensitive skin or sensitive to benzoyl peroxide.

​warnings (​Warnings)

​For external use only.

​directions: (​Directions:)

Shake before using.  Apply to clean skin.  Cover the affected area with a thin layer 1 to 3 times daily.  Because too much drying of the skin may occur, start with 1 application daily or every other day, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.  If bothersome dryness or peeling occurs, reduce applicaction once a day or every other day.  If going outside, allow product to dry, then use a sunscreen.  Store at 20-25 ​C (68-77 ​F) ​o ​o

Package Labeling:

​active Ingredient (​Active Ingredient)

Benzoyl Peroxide 3%

​inactive Ingredients (​Inactive Ingredients)

Aqua purificata (purified water), C12-15 Alkyl Benzoate, Urea, Butylene Glycol, Cyclopentasiloxane, Magnesium aluminum silicated, Steareth-20, Peg-100 stearate, Zea mays (corn) starch, Hydroxyethyl acrylate/sodium acryloydimethyl, Taurate copolymer, Squalane, Polysorbate 60, Chamomilla recutita (matricaria) extract, Camellia oleifera leaf extract, Phospholipids, Retinyl palmitate, Tocopherol, Ascorbyl palmitate, Beta-carotene, Ethylhexylglycerin, Cetearyl alcohol, Glycerin, Caprylyl glycol, Dimethicone, Acrylates/C10-30 alkyl acrylate crosspolymer, Steareth-2, Butylene Glycol, Propylene glycol, Panthenol, Disodium EDTA, Allantoin, Phytonadione.

​when Using This Product: (​When using this product:)

Apply to affected areas only.  Avoid unnecessary sun exposure and use a sunscreen.  Do not use in or near the eyes, lips or mouth.  This product may bleach hair or dyed fabrics.  Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin.

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.

Discontinue Use and Ask A Doctor (Discontinue use and ask a doctor)

 if skin irritation becomes severe or if you are using more than one acne medication.


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