Naturium Benzoyl Peroxide Cream Cleanser 5%

Naturium Benzoyl Peroxide Cream Cleanser 5%
SPL v3
SPL
SPL Set ID 0a278590-e98b-7cab-e063-6394a90a4d0e
Route
TOPICAL
Published
Effective Date 2022-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Sodium Hydroxide Water Carbomer Homopolymer, Unspecified Type Sodium Cocoyl Isethionate Aloe Vera Leaf Xylitol Xanthan Gum Carbomer Interpolymer Type A (55000 Cps) Phenoxyethanol Sodium Benzoate Propanediol Cocamidopropyl Betaine Glycerin N-acetylglucosamine Sodium Methyl Cocoyl Taurate Sodium Phosphate Cocamidopropyl Hydroxysultaine Sodium Citrate Docusate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-17

Description

Benzoyl Peroxide 5.00%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 5.00%

Uses
  • Helps fight existing acne breakouts and prevents future acne breakouts.
Warnings

For external use only.

Directions

Shake Well.

  • gently massage a dime size amount on damp skin to cleanse thoroughly. Avoid eye area.
  • cover the entire affected area and rinse thoroughly.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or two 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.
Active Ingredient

Benzoyl Peroxide 5.00%

Do Not Use If You
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information

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. Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.

Product Packaging

Inactive Ingredients

Aqua (Water), Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Glycerin, Cocamidopropyl Hydroxysultaine, Acetyl Glucosamine, Aloe Barbadensis Leaf Juice, Sodium Methyl Cocoyl Taurate, Xylitol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Benzoate, Sodium Phosphate, Sodium Citrate, Propanediol, Diethylhexyl Sodium Sulfosuccinate, Carbomer, Sodium Hydroxide.

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 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.
Stop Use and Ask A Doctor If
  • irritation becomes severe
​keep Out of Reach of Children.

​Keep out of reach of children.


Structured Label Content

Uses
  • Helps fight existing acne breakouts and prevents future acne breakouts.
Purpose

Acne Treatment

Warnings

For external use only.

Directions

Shake Well.

  • gently massage a dime size amount on damp skin to cleanse thoroughly. Avoid eye area.
  • cover the entire affected area and rinse thoroughly.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or two 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.
Active Ingredient

Benzoyl Peroxide 5.00%

Do Not Use If You (Do not use if you)
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information

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. Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.

Product Packaging

Inactive Ingredients

Aqua (Water), Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Glycerin, Cocamidopropyl Hydroxysultaine, Acetyl Glucosamine, Aloe Barbadensis Leaf Juice, Sodium Methyl Cocoyl Taurate, Xylitol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Benzoate, Sodium Phosphate, Sodium Citrate, Propanediol, Diethylhexyl Sodium Sulfosuccinate, Carbomer, Sodium Hydroxide.

When Using This Product (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 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.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation becomes severe
​keep Out of Reach of Children. (​Keep out of reach of children.)

​Keep out of reach of children.


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