111medco Benzoyl Peroxide Acne Cleansing Bar

111medco Benzoyl Peroxide Acne Cleansing Bar
SPL v9
SPL
SPL Set ID 8590214e-e5a7-8934-e053-2a91aa0a248b
Route
TOPICAL
Published
Effective Date 2019-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Cetostearyl Alcohol Sodium Cocoyl Isethionate Tetrasodium Glutamate Diacetate Water Glycerin Sodium Chloride Decyl Glucoside

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-02

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

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

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

Section 50565-1

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

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

Aqua, Cetearyl Alcohol, Decyl Glucoside, Dextrin, Glycerin, Sodium Chloride, Sodium Cocoyl Isethionate, Tetrasodium Glutamate Diacetate

Section 51945-4

111 Medco

10% BENZOYL PEROXIDE

FOR ACNE

cleansing bar

Net Wt 4 OZ (113 g)

Section 55105-1

Purpose

Acne medication

Section 55106-9

Active ingredient

Benzoyl peroxide 10%


Structured Label Content

Indications and Usage (34067-9)

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

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)

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

Section 50565-1 (50565-1)

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

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

Aqua, Cetearyl Alcohol, Decyl Glucoside, Dextrin, Glycerin, Sodium Chloride, Sodium Cocoyl Isethionate, Tetrasodium Glutamate Diacetate

Section 51945-4 (51945-4)

111 Medco

10% BENZOYL PEROXIDE

FOR ACNE

cleansing bar

Net Wt 4 OZ (113 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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