Obagi®

Obagi®
SPL v1
SPL
SPL Set ID 1904602f-0979-4002-a408-ddcd07cde429
Route
TOPICAL
Published
Effective Date 2012-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Benzyl Benzoate Dicaprylyl Ether Propylene Glycol Squalane Polysorbate 60 Dimethyl Isosorbide Phenoxyethanol Edetate Disodium Butylated Hydroxytoluene Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2007-07-01

Description

DRUG FACTS

Purpose

Acne treatment lotion


Medication Information

Purpose

Acne treatment lotion

Description

DRUG FACTS

Uses
  • for the treatment of acne
  • dries up acne pimples
  • helps prevent new acne pimples
Section 42229-5

DRUG FACTS

Section 53414-9
  • If pregnant or breast-feeding, ask a health care professional before use.
Warnings

For external use only.

Directions
  • clean the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one to three 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.
Questions?

1-800-636-7546 Mon-Fri 9:00 am – 4:00 pm PST

Active Ingredient

Benzoyl Peroxide 5%

Do Not Use If You
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information
  • store away from heat and direct sunlight.
  • store at controlled room temperature: 15°-25°C (59°-77°F).
Inactive Ingredients

Benzyl Benzoate, BHT, Dicaprylyl Ether, Dimethyl Isosorbide, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Squalane, Water (Aqua).

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.
Stop Use and Ask A Doctor If
  • irritation becomes severe.
Keep Out of Reach of Children

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

Principal Display Panel 47 Ml Bottle Label

OBAGI ®

CLENZIderm M.D.™

Therapeutic

Lotion

BENZOYL PEROXIDE 5%

2

SoluZyl Technology™


delivers medication

deep within your

pores where acne

starts. Helps to

clear acne quickly

while minimizing

dryness.

1.6 FL. OZ. (47 mL)


Structured Label Content

Uses
  • for the treatment of acne
  • dries up acne pimples
  • helps prevent new acne pimples
Section 42229-5 (42229-5)

DRUG FACTS

Section 53414-9 (53414-9)
  • If pregnant or breast-feeding, ask a health care professional before use.
Purpose

Acne treatment lotion

Warnings

For external use only.

Directions
  • clean the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one to three 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.
Questions?

1-800-636-7546 Mon-Fri 9:00 am – 4:00 pm PST

Active Ingredient

Benzoyl Peroxide 5%

Do Not Use If You (Do not use if you)
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information
  • store away from heat and direct sunlight.
  • store at controlled room temperature: 15°-25°C (59°-77°F).
Inactive Ingredients

Benzyl Benzoate, BHT, Dicaprylyl Ether, Dimethyl Isosorbide, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Polysorbate 60, Propylene Glycol, Squalane, Water (Aqua).

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.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation becomes severe.
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.

Principal Display Panel 47 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 47 mL Bottle Label)

OBAGI ®

CLENZIderm M.D.™

Therapeutic

Lotion

BENZOYL PEROXIDE 5%

2

SoluZyl Technology™


delivers medication

deep within your

pores where acne

starts. Helps to

clear acne quickly

while minimizing

dryness.

1.6 FL. OZ. (47 mL)


Advanced Ingredient Data


Raw Label Data

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