Cvs Acne Cleansing Bar

Cvs Acne Cleansing Bar
SPL v3
SPL
SPL Set ID 42b45112-663f-2925-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Sodium Cocoyl Isethionate Ethylene-vinyl Acetate Copolymer (15% Vinyl Acetate) Stearic Acid Sodium Tallowate, Beef Coconut Acid Water Sodium Isethionate Starch, Corn Sodium Cocoate Glycerin Titanium Dioxide Mineral Oil Cocamidopropyl Betaine Etidronate Tetrasodium Sodium Chloride Edetate Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-01-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use for the treatment of acne; helps prevent new acne blemishes from forming

Dosage and Administration

Directions • using warm water, wash the affected area for 1 to 2 minutes • rinse well and pat dry with a clean towel • because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 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 outside, apply sunscreen after using the product • If irritation or sensitivity develops, stop use of both products and ask a doctor.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information Store at controlled room temperature 59° - 86°F (15° - 30°C)

Section 50565-1

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

Section 50566-9

Stop use and consult a doctor if • irritation becomes severe.

Section 50567-7

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.

Section 50570-1

Do not use • if you have very sensitive skin • if you are sensitive to benzoyl peroxide

Section 51727-6

Inactive ingredients sodium cocoyl isethionate, stearic acid, coconut acid, water, sodium isethionate, ethylene/VA copolymer, zea mays (corn) starch, sodium tallowate, titanium dioxide, mineral oil, cocamidopropyl betaine, tetrasodium etidronate, sodium cocoate, glycerin, sodium chloride, tetrasodium EDTA

Section 51945-4

CVS Health™

MAXIMUM STRENGTH

Acne Cleansing Bar

10% BENZOYL PEROXIDE

• For treatment of acne on face, chest & back

• Benzoyl Peroxide helps prevent new acne blemishes from forming

• Clears existing acne

NET WT 4.8 OZ (136 g)

Section 55105-1

Purpose

Acne medication

Section 55106-9

Active ingredient

Benzoyl peroxide 10%


Structured Label Content

Indications and Usage (34067-9)

Use for the treatment of acne; helps prevent new acne blemishes from forming

Dosage and Administration (34068-7)

Directions • using warm water, wash the affected area for 1 to 2 minutes • rinse well and pat dry with a clean towel • because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 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 outside, apply sunscreen after using the product • If irritation or sensitivity develops, stop use of both products and ask a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information Store at controlled room temperature 59° - 86°F (15° - 30°C)

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and consult a doctor if • irritation becomes severe.

Section 50567-7 (50567-7)

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.

Section 50570-1 (50570-1)

Do not use • if you have very sensitive skin • if you are sensitive to benzoyl peroxide

Section 51727-6 (51727-6)

Inactive ingredients sodium cocoyl isethionate, stearic acid, coconut acid, water, sodium isethionate, ethylene/VA copolymer, zea mays (corn) starch, sodium tallowate, titanium dioxide, mineral oil, cocamidopropyl betaine, tetrasodium etidronate, sodium cocoate, glycerin, sodium chloride, tetrasodium EDTA

Section 51945-4 (51945-4)

CVS Health™

MAXIMUM STRENGTH

Acne Cleansing Bar

10% BENZOYL PEROXIDE

• For treatment of acne on face, chest & back

• Benzoyl Peroxide helps prevent new acne blemishes from forming

• Clears existing acne

NET WT 4.8 OZ (136 g)

Section 55105-1 (55105-1)

Purpose

Acne medication

Section 55106-9 (55106-9)

Active ingredient

Benzoyl peroxide 10%


Advanced Ingredient Data


Raw Label Data

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