Obagi

Obagi
SPL v1
SPL
SPL Set ID f21778c7-d730-48a6-a0f9-5f6e550b8cf0
Route
TOPICAL
Published
Effective Date 2011-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (5 mg)
Inactive Ingredients
Stearyl Alcohol Cyclomethicone 5 Glyceryl Monostearate Peg-100 Stearate Cetyl Alcohol Glycerin Lactic Acid Methylparaben Allantoin Propylparaben Edetate Sodium Butylparaben Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1988-01-01

Description

Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Drug Facts

Uses
  • Provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes from:
    • Eczema
    • Psoriasis
    • Insect bites
    • Seborrheic dermatitis
    • Soaps
    • Poison ivy
    • Poison oak
    • Poison sumac
    • Jewelry
    • Cosmetics
    • Detergents
  • Other uses of this product should be only under the advice and supervision of a doctor.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9

Stop use and ask a doctor if

  • Symptoms last for more than 7 days.
  • The condition gets worse.
  • Symptoms clear up and come back in a few days.
Section 50567-7

When using this product do not begin the use of any other hydrocortisone product.

Warnings
  • For external use only.
Directions
  • Adults and children 2 years and older: apply to the affected area not more than 3 to 4 times daily.
  • Children under 2 years of age, do not use, ask a doctor.
Do Not Use
  • In the eyes.
  • For the treatment of diaper rash.
Other Information
  • Store at room temperature. Protect from freezing and excessive heat.
Active Ingredients

Hydrocortisone, 0.5%

Inactive Ingredients

allantoin, butylparaben, cetyl alcohol, cyclopentasiloxane, glycerin, glyceryl stearate, lactic acid, methylparaben, PEG-100 stearate, propylparaben, purified water, saponins, stearyl alcohol, tetrasodium EDTA.

Principal Display Panel 57g Bottle Carton

OBAGI

NU-DERM®

TOLEREEN

ANTI-PRURITIC

LOTION

HYDROCORTISONE

USP, 0.5%

NET WT. 2 OZ. (57g)


Structured Label Content

Uses
  • Provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes from:
    • Eczema
    • Psoriasis
    • Insect bites
    • Seborrheic dermatitis
    • Soaps
    • Poison ivy
    • Poison oak
    • Poison sumac
    • Jewelry
    • Cosmetics
    • Detergents
  • Other uses of this product should be only under the advice and supervision of a doctor.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Symptoms last for more than 7 days.
  • The condition gets worse.
  • Symptoms clear up and come back in a few days.
Section 50567-7 (50567-7)

When using this product do not begin the use of any other hydrocortisone product.

Purpose

Anti-itch

Warnings
  • For external use only.
Directions
  • Adults and children 2 years and older: apply to the affected area not more than 3 to 4 times daily.
  • Children under 2 years of age, do not use, ask a doctor.
Do Not Use (Do not use)
  • In the eyes.
  • For the treatment of diaper rash.
Other Information (Other information)
  • Store at room temperature. Protect from freezing and excessive heat.
Active Ingredients (Active ingredients)

Hydrocortisone, 0.5%

Inactive Ingredients (Inactive ingredients)

allantoin, butylparaben, cetyl alcohol, cyclopentasiloxane, glycerin, glyceryl stearate, lactic acid, methylparaben, PEG-100 stearate, propylparaben, purified water, saponins, stearyl alcohol, tetrasodium EDTA.

Principal Display Panel 57g Bottle Carton (PRINCIPAL DISPLAY PANEL - 57g Bottle Carton)

OBAGI

NU-DERM®

TOLEREEN

ANTI-PRURITIC

LOTION

HYDROCORTISONE

USP, 0.5%

NET WT. 2 OZ. (57g)


Advanced Ingredient Data


Raw Label Data

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