Signature Care 10% Benzoyl Peroxide Acne Medication

Signature Care 10% Benzoyl Peroxide Acne Medication
SPL v2
SPL
SPL Set ID a62af431-b033-3603-e053-2995a90a961e
Route
TOPICAL
Published
Effective Date 2020-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Edetate Disodium Hypromellose 2910 (4000 Mpa.s) Laureth-4 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-08

Description

Benzoyl Peroxide 10%

Purpose

Acne Medication


Medication Information

Purpose

Acne Medication

Description

Benzoyl Peroxide 10%

Uses

for the treatment of acne

Section 50565-1

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

Section 50569-3

Stop use and ask a doctor if • irritation becomes severe

Section 50570-1

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

Section 51945-4

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

1 OZ (28.3g)

NDC 21130-730-16

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

BLISTER PACK

NDC 21130-730-17

Warnings

For external use only

directions
  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily
  • Becasue 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 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.
Inactive Ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

active Ingredient

Benzoyl Peroxide 10%

when Using This Product
  • avoid contact with the eyes, lips, and mouth
  • avoid unnecessary sun exposure and use a sunscreen
  • 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.
  • 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.

Structured Label Content

Uses

for the treatment of acne

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 50569-3 (50569-3)

Stop use and ask a doctor if • irritation becomes severe

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

1 OZ (28.3g)

NDC 21130-730-16

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

BLISTER PACK

NDC 21130-730-17

Purpose

Acne Medication

Warnings

For external use only

directions (Directions)
  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily
  • Becasue 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 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.
Inactive Ingredients (Inactive ingredients)

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

active Ingredient (Active ingredient)

Benzoyl Peroxide 10%

when Using This Product (When using this product)
  • avoid contact with the eyes, lips, and mouth
  • avoid unnecessary sun exposure and use a sunscreen
  • 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.
  • 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.

Advanced Ingredient Data


Raw Label Data

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