Drug Facts - Oxy Advanced Care Rapid Spot Treatment

Drug Facts - Oxy Advanced Care Rapid Spot Treatment
SPL v3
SPL
SPL Set ID e613e8a6-ffed-49bc-bdc0-87606c51ffa3
Route
TOPICAL
Published
Effective Date 2022-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Water Glycerin Butylene Glycol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Chlorphenesin Anhydrous Citric Acid Dimethyl Isosorbide Edetate Disodium Hydrated Silica Soy Protein Lauryl Methacrylate/glycol Dimethacrylate Crosspolymer Peg/ppg-4/12 Dimethicone Phenoxyethanol Purslane Propanediol Rhodomyrtus Tomentosa Fruit Sodium Citrate, Unspecified Form Sodium Hydroxide Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-31

Description

Benzoyl peroxide 10%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Benzoyl peroxide 10%

Uses
  • for the treatment of acne
  • helps prevent new acne blemishes from forming
Warnings

For external use only

Questions

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

Directions
  • clean the skin thoroughly before applying this product
  • cover the 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

water, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, fragrance, hydrated silica, hydrolyzed soy protein, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, 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 the product less frequently or in a lower concentration.
Other Safety Information
  • avoid storing at temperatures above 100 OF (38 OC)
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
  • for the treatment of acne
  • helps prevent new acne blemishes from forming
Purpose

Acne treatment

Warnings

For external use only

Questions

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

Directions
  • clean the skin thoroughly before applying this product
  • cover the 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

water, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, fragrance, hydrated silica, hydrolyzed soy protein, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, 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 the product less frequently or in a lower concentration.
Other Safety Information
  • avoid storing at temperatures above 100 OF (38 OC)
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. (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)

Advanced Ingredient Data


Raw Label Data

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