Pca Skin Acne Cream

Pca Skin Acne Cream
SPL v26
SPL
SPL Set ID 257bd9dd-93f9-4996-8478-8198be3ef683
Route
TOPICAL
Published
Effective Date 2022-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g)
Inactive Ingredients
Aloe Vera Leaf Water Glycerin Allantoin Panthenol Phenoxyethanol Hexylene Glycol Caprylyl Glycol Polysorbate 20 Butylene Glycol Gluconolactone Cetyl Alcohol Grape Aminomethylpropanol Lactic Acid Citrus Paradisi Seed Tea Tree Oil Chamaemelum Nobile Flower Glyceryl Monostearate Polyoxyl 100 Stearate Dimethicone Cyclomethicone 5 Ascorbic Acid .alpha.-tocopherol Acetate, D- Vitamin A Palmitate Ethylhexylglycerin Potassium Cetyl Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-04-01 Until 2021-08-31

Description

ACTIVE INGREDIENT:                 Benzoyl Peroxide (5.0%)                      


Medication Information

Warnings and Precautions


WARNINGS:

  • When using this product, avoid unnecessary sun exposure and use a sunscreen.
  • For external use only
  • Using other topical acne drugs at the same time or immediately following the use of this product may increase dryness or irritation of the skin.  If this occurs, only one drug should be used unless directed by a physician.
  • Do not use in or near the eyes.
Indications and Usage

USES:

  • Treats existing and helps prevent new acne blemishes/blackheads.

Dosage and Administration

DIRECTIONS: Cleanse skin thoroughly before applying.  Apply a small amount of cream to areas where pimples occur.  Do not rinse.   Start with one acne treatment every other day and gradually increase to once daily or as directed by a physician. If going outside, use a sunscreen. Allow Acne Cream to dry, then follow sunscreen label directions.  If irritation develops or sensitivity develops, discontinue use of both products and consult a physician.

Description

ACTIVE INGREDIENT:                 Benzoyl Peroxide (5.0%)                      

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Immediately.

Section 51727-6

Other Ingredients: Water/Aqua/Eau, Gluconolactone, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Vitis Vinifera (Grape) Seed Oil, Aminomethyl Propanol, Lactic Acid, Aloe Barbadensis Leaf Juice, Cyclopentasiloxane, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Melaleuca Arternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Anthemis Nobilis Flower Extract, Citrus Grandis (Grapefruit) Peel Oil, Allantoin, Panthenol, Polyacrylate-13, Polyisobutene, Caprylyl Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Potassium Cetyl Phosphate, Ethylhexylglycerin, Hexylene Glycol, Polysorbate 20, Butylene Glycol, Phenoxyethanol.

Section 51945-4

Section 55105-1

Purpose: Acne Treatment

Section 55106-9

ACTIVE INGREDIENT:                 Benzoyl Peroxide (5.0%)                      


Structured Label Content

Indications and Usage (34067-9)

USES:

  • Treats existing and helps prevent new acne blemishes/blackheads.

Dosage and Administration (34068-7)

DIRECTIONS: Cleanse skin thoroughly before applying.  Apply a small amount of cream to areas where pimples occur.  Do not rinse.   Start with one acne treatment every other day and gradually increase to once daily or as directed by a physician. If going outside, use a sunscreen. Allow Acne Cream to dry, then follow sunscreen label directions.  If irritation develops or sensitivity develops, discontinue use of both products and consult a physician.

Warnings and Precautions (34071-1)


WARNINGS:

  • When using this product, avoid unnecessary sun exposure and use a sunscreen.
  • For external use only
  • Using other topical acne drugs at the same time or immediately following the use of this product may increase dryness or irritation of the skin.  If this occurs, only one drug should be used unless directed by a physician.
  • Do not use in or near the eyes.
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Immediately.

Section 51727-6 (51727-6)

Other Ingredients: Water/Aqua/Eau, Gluconolactone, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Vitis Vinifera (Grape) Seed Oil, Aminomethyl Propanol, Lactic Acid, Aloe Barbadensis Leaf Juice, Cyclopentasiloxane, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Melaleuca Arternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Anthemis Nobilis Flower Extract, Citrus Grandis (Grapefruit) Peel Oil, Allantoin, Panthenol, Polyacrylate-13, Polyisobutene, Caprylyl Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Potassium Cetyl Phosphate, Ethylhexylglycerin, Hexylene Glycol, Polysorbate 20, Butylene Glycol, Phenoxyethanol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Acne Treatment

Section 55106-9 (55106-9)

ACTIVE INGREDIENT:                 Benzoyl Peroxide (5.0%)                      


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)