Drug Facts - Oxy 10 Acne Cleanser

Drug Facts - Oxy 10 Acne Cleanser
SPL v6
SPL
SPL Set ID 35dbfe37-992d-4c9c-a4be-707d32370c76
Route
TOPICAL
Published
Effective Date 2018-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Water Cetostearyl Alcohol Sodium C14-16 Olefin Sulfonate Disodium Laureth Sulfosuccinate Capryl/capramidopropyl Betaine Xanthan Gum Butylene Glycol Anhydrous Citric Acid Diazolidinyl Urea Soy Protein Hydroxyphenyl Propamidobenzoic Acid Methylparaben Peg-8 Dimethicone Pentylene Glycol Propylparaben Sodium Citrate, Unspecified Form Sodium Hydroxide Sodium Lauroyl Sarcosinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-01

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
  • wet face
  • apply to hands then work into a lather and massage gently onto face
  • rinse thoroughly and pat dry
  • because excessive drying of the skin may occur, start with 1 use 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 usage 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.
  • Sensitivity Test: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.
Questions?

1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

Active Ingredient

Benzoyl peroxide 10%

Do Not Use If You
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information
  • THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
  • KEEP TIGHTLY CLOSED
  • avoid storing at temperatures above 100°F (38°C)
Inactive Ingredients

water, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, citric acid, diazolidinyl urea, fragrance, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, methylparaben, PEG-8 dimethicone, pentylene glycol, propylparaben, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

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
  • wet face
  • apply to hands then work into a lather and massage gently onto face
  • rinse thoroughly and pat dry
  • because excessive drying of the skin may occur, start with 1 use 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 usage 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.
  • Sensitivity Test: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.
Questions?

1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

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
Other Information (Other information)
  • THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
  • KEEP TIGHTLY CLOSED
  • avoid storing at temperatures above 100°F (38°C)
Inactive Ingredients (Inactive ingredients)

water, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, citric acid, diazolidinyl urea, fragrance, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, methylparaben, PEG-8 dimethicone, pentylene glycol, propylparaben, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

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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