Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c
Route
TOPICAL
Published
Effective Date 2024-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Medium-chain Triglycerides Polyoxyl 20 Cetostearyl Ether Chamomile Ethylhexylglycerin Glycerin Glyceryl Monostearate Myristic Acid Petrolatum Phenoxyethanol Stearic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-28

Description

Hydrocortisone Acetate USP w/w (1.0 %).

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone Acetate USP w/w (1.0 %).

Uses:

For temporary relief of itching associated with minor skin irritation and rashes due to:

  • Atopic eczema
  • Contact dermatitis from soaps, detergents, or cosmetics
  • Seborrheic dermatitis
  • Psoriasis

Other uses of this product should be only under the advice and supervision of a doctor.

Section 42229-5

Adults and Children 2 Years and Older: Apply to the affected area not more than 3 to 4 times daily.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings:

For external use only.

Do Not Use:
  • for the treatment of diaper rash
  • on children under the age of 2 except under the supervision of a doctor.
Active Ingredient

Hydrocortisone Acetate USP w/w (1.0 %).

Other Information

Store at controlled room temperature 20º-25ºC (68-77ºF)

Inactive Ingredients

Caprylic/Capric Triglyceride, Ceteareth-20, Chamomilla Recutita Flower Extract, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Myristic Acid, Petrolatum, Phenoxyethanol, Stearic Acid, Water.

Questions Or Comments

Call 1-800-925-4733

When Using This Product:
  • avoid contact with the eyes
  • do not begin use of any other hydrocortisone product unless directed by a doctor.
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days.
Principal Display Panel – 56 G Carton Label

Walgreens

Compare to the active ingredient in

Exederm® Flare Control Cream††

WALGREENS PHARMACIST RECOMMENDED

Eczema Relief Cream

  • Fast, soothing relief from itching, inflammation, redness & rash

For eczema & dermatitis

Eczema Relief Cream

1% HYDROCORTISONE ACETATE ANTI-ITCH CREAM

NET WT 2 OZ (56 g)


Structured Label Content

Uses:

For temporary relief of itching associated with minor skin irritation and rashes due to:

  • Atopic eczema
  • Contact dermatitis from soaps, detergents, or cosmetics
  • Seborrheic dermatitis
  • Psoriasis

Other uses of this product should be only under the advice and supervision of a doctor.

Section 42229-5 (42229-5)

Adults and Children 2 Years and Older: Apply to the affected area not more than 3 to 4 times daily.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anti-itch

Warnings:

For external use only.

Do Not Use: (Do not use:)
  • for the treatment of diaper rash
  • on children under the age of 2 except under the supervision of a doctor.
Active Ingredient

Hydrocortisone Acetate USP w/w (1.0 %).

Other Information

Store at controlled room temperature 20º-25ºC (68-77ºF)

Inactive Ingredients

Caprylic/Capric Triglyceride, Ceteareth-20, Chamomilla Recutita Flower Extract, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Myristic Acid, Petrolatum, Phenoxyethanol, Stearic Acid, Water.

Questions Or Comments (Questions or Comments)

Call 1-800-925-4733

When Using This Product: (When using this product:)
  • avoid contact with the eyes
  • do not begin use of any other hydrocortisone product unless directed by a doctor.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days.
Principal Display Panel – 56 G Carton Label (Principal Display Panel – 56 g Carton Label)

Walgreens

Compare to the active ingredient in

Exederm® Flare Control Cream††

WALGREENS PHARMACIST RECOMMENDED

Eczema Relief Cream

  • Fast, soothing relief from itching, inflammation, redness & rash

For eczema & dermatitis

Eczema Relief Cream

1% HYDROCORTISONE ACETATE ANTI-ITCH CREAM

NET WT 2 OZ (56 g)


Advanced Ingredient Data


Raw Label Data

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