Drug Facts - Oxy 10

Drug Facts - Oxy 10
SPL v4
SPL
SPL Set ID d499b69a-25aa-4e3d-a07e-a774bc0d65f1
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
Anhydrous Citric Acid Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Diazolidinyl Urea Dimethicone Docusate Sodium Edetate Disodium Glycerin Lauryl Methacrylate/glycol Dimethacrylate Crosspolymer Propylene Glycol Water Silicon Dioxide Sodium Citrate Sodium Hydroxide Xanthan Gum

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

anhydrous citric acid, carbomer homopolymer, diazolidinyl urea, diethylhexyl sodium sulfosuccinate, dimethicone, edetate disodium, glycerin, lauryl methacrylate/glycol dimethacrylate crosspolymer, propylene glycol, purified water, silica, sodium citrate, sodium hydroxide, xanthan gum

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.

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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

anhydrous citric acid, carbomer homopolymer, diazolidinyl urea, diethylhexyl sodium sulfosuccinate, dimethicone, edetate disodium, glycerin, lauryl methacrylate/glycol dimethacrylate crosspolymer, propylene glycol, purified water, silica, sodium citrate, sodium hydroxide, xanthan gum

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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