Drug Facts - Oxy 10 Tinted

Drug Facts - Oxy 10 Tinted
SPL v4
SPL
SPL Set ID 0ceee85d-dc8c-49b3-9b44-8fe60022c243
Route
TOPICAL
Published
Effective Date 2015-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Docusate Sodium Edetate Disodium Ferric Oxide Red Water Sodium Hydroxide Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-07-01

Description

Benzoyl peroxide 10%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Benzoyl peroxide 10%

Uses

treats and helps prevent acne

Warnings

For external use only

Directions
  • clean skin thoroughly before applying this product
  • cover entire affected area with a thin layer 1 to 3 times daily
  • because excessive 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 this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Active Ingredient

Benzoyl peroxide 10%

Do Not Use If You
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Inactive Ingredients

carbomer homopolymer, diethylhexyl sodium sulfosuccinate, edetate disodium, iron oxide, purified water, sodium hydroxide, talc, titanium dioxide

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 this product less frequently or in a lower concentration.
Stop Use and Ask A Doctor If

irritation becomes severe

If Pregnant Or Breast Feeding

Ask a health professional before use.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

Structured Label Content

Uses

treats and helps prevent acne

Purpose

Acne treatment

Warnings

For external use only

Directions
  • clean skin thoroughly before applying this product
  • cover entire affected area with a thin layer 1 to 3 times daily
  • because excessive 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 this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Active Ingredient (Active ingredient)

Benzoyl peroxide 10%

Do Not Use If You (Do Not Use if you)
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Inactive Ingredients

carbomer homopolymer, diethylhexyl sodium sulfosuccinate, edetate disodium, iron oxide, purified water, sodium hydroxide, talc, titanium dioxide

When Using This Product (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 this product less frequently or in a lower concentration.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation becomes severe

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

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