Hyr Acne Wash (benzoyl Peroxide 5%)

Hyr Acne Wash (benzoyl Peroxide 5%)
SPL v1
SPL
SPL Set ID b1f656c1-cb52-0ea0-e053-2a95a90aae0e
Route
TOPICAL
Published
Effective Date 2020-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g)
Inactive Ingredients
Sodium C14-16 Olefin Sulfonate Water Sodium Benzoate Stearic Acid Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-10-19

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

for the treatment of acne

Dosage and Administration

Directions

  • shake well
  • wet affected area and apply product in a thin layer one to three times daily. Rinse well and pat dry.
  • 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 directed by a doctor.
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, use a sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation becomes severe

Section 50567-7

When using this product

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with 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
  • 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.
Section 50570-1

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Section 51727-6

Inactive ingredients carbomer, purified water, sodium benzoate, sodium C14-16 olefin sulfonate, stearic acid

Section 51945-4

HYR

ACNE WASH

Benzoyl Peroxide USP, 5%

Net 2 fl oz (60 ml)

Proudly made in the USA

Section 55105-1

Purpose

Acne Treatment

Section 55106-9

Active ingredient

Benzoyl Peroxide USP, 5%


Structured Label Content

Indications and Usage (34067-9)

Uses

for the treatment of acne

Dosage and Administration (34068-7)

Directions

  • shake well
  • wet affected area and apply product in a thin layer one to three times daily. Rinse well and pat dry.
  • 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 directed by a doctor.
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, use a sunscreen after using this 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 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation becomes severe

Section 50567-7 (50567-7)

When using this product

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with 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
  • 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.
Section 50570-1 (50570-1)

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Section 51727-6 (51727-6)

Inactive ingredients carbomer, purified water, sodium benzoate, sodium C14-16 olefin sulfonate, stearic acid

Section 51945-4 (51945-4)

HYR

ACNE WASH

Benzoyl Peroxide USP, 5%

Net 2 fl oz (60 ml)

Proudly made in the USA

Section 55105-1 (55105-1)

Purpose

Acne Treatment

Section 55106-9 (55106-9)

Active ingredient

Benzoyl Peroxide USP, 5%


Advanced Ingredient Data


Raw Label Data

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