Drug Facts - Oxy Total Care Clarifying Moisturizer

Drug Facts - Oxy Total Care Clarifying Moisturizer
SPL v4
SPL
SPL Set ID 4568b5d1-efde-4b2f-b7cc-8d227d05dfa1
Route
TOPICAL
Published
Effective Date 2019-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (25 mg)
Inactive Ingredients
Edetate Disodium Hyaluronic Acid Alginic Acid Lauryl Methacrylate/glycol Dimethacrylate Crosspolymer Peg/ppg-4/12 Dimethicone Phenoxyethanol Fytic Acid Purslane Silanetriol Trisodium Citrate Dihydrate Sodium Hydroxide Xanthan Gum Zinc Sulfate Heptahydrate Water Glycerin Butylene Glycol Carboxypolymethylene Chlorphenesin Anhydrous Citric Acid Dimethyl Isosorbide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-30

Description

Benzoyl peroxide 2.5%

Purpose

Benzoyl peroxide – Acne treatment


Medication Information

Purpose

Benzoyl peroxide – Acne treatment

Description

Benzoyl peroxide 2.5%

Uses
  • For the treatment of acne.
  • Helps prevent new acne blemishes.
Warnings

For external use only.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

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, use only 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.

Stop use and ask a doctor if irritation becomes severe.

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • clean the skin thoroughly before applying this product
  • use a dime-sized amount to cover the entire affected area with a thin layer one to two times daily
  • 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 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.
  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Other information

  • THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
  • KEEP TIGHTLY CLOSED
  • avoid storing at temperatures above 100°F (38°C)
Active Ingredient

Benzoyl peroxide 2.5%

Inactive Ingredients

water, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, hyaluronic acid, hydrolyzed algin, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, phytic acid, portulaca oleracea extract, silanetriol, sodium citrate, sodium hydroxide, xanthan gum, zinc sulfate

Questions? 1-877-636-2677

MON-FRI 9AM-5PM (EST)

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.
Purpose

Benzoyl peroxide – Acne treatment

Warnings

For external use only.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

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, use only 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.

Stop use and ask a doctor if irritation becomes severe.

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • clean the skin thoroughly before applying this product
  • use a dime-sized amount to cover the entire affected area with a thin layer one to two times daily
  • 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 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.
  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Other information

  • THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
  • KEEP TIGHTLY CLOSED
  • avoid storing at temperatures above 100°F (38°C)
Active Ingredient (Active ingredient)

Benzoyl peroxide 2.5%

Inactive Ingredients

water, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, hyaluronic acid, hydrolyzed algin, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, phytic acid, portulaca oleracea extract, silanetriol, sodium citrate, sodium hydroxide, xanthan gum, zinc sulfate

Questions? 1-877-636-2677

MON-FRI 9AM-5PM (EST)

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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