Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 9f33ffc7-2727-491e-a361-7f130c81d1b1
Route
TOPICAL
Published
Effective Date 2017-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g)
Inactive Ingredients
Water Glycerin Propylene Glycol Sorbitol Cucumis Sativus Whole Rosmarinus Officinalis Whole Aloe Vera Leaf Matricaria Chamomilla Triethanolamine Dioleate Carbomer 940 Disodium Edta-copper Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-30

Description

Benzoyl Peroxide 5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 5%

Uses
  • Treats Acne
  • Helps prevent the development of new acne blemishes
Warnings

Using other topical acne medications at the same tiem or immediatly following use of this prouct may increase dryness or irritation of the skin. If this occurs, only one medication shoul be used unless directed by a doctor.

For external use only

When using this product

• avoid contact with the eyes

• if contact occurs, rinse thoroughly with water

• do not use on damaged or broken skin

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 or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce use to once a day or every other ay
Active Ingredients

Benzoyl Peroxide 5%

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Sorbitol, Cucumis Sativa (Cucumber) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Triethanolamine, Carbomer, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin

Principal Display Panel

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.


Structured Label Content

Uses
  • Treats Acne
  • Helps prevent the development of new acne blemishes
Purpose

Acne Treatment

Warnings

Using other topical acne medications at the same tiem or immediatly following use of this prouct may increase dryness or irritation of the skin. If this occurs, only one medication shoul be used unless directed by a doctor.

For external use only

When using this product

• avoid contact with the eyes

• if contact occurs, rinse thoroughly with water

• do not use on damaged or broken skin

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 or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce use to once a day or every other ay
Active Ingredients

Benzoyl Peroxide 5%

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Sorbitol, Cucumis Sativa (Cucumber) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Triethanolamine, Carbomer, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin

Principal Display Panel

Keep Out of Reach of Children (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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