SPL v5
SPL
SPL Set ID 4346351c-8e11-46ae-b428-98d17f55beb9
Route
TOPICAL
Published
Effective Date 2023-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Glycerin Water Petrolatum Medium-chain Triglycerides Glyceryl Stearate Se Palmitic Acid Polyoxyl 20 Cetostearyl Ether Chamomile Anhydrous Citric Acid Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-01-24

Description

Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Drug Facts

Uses:

For temporary relief of itching associated with minor skin irritation, inflammation 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

Drug Facts

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 1.0% w/w

Other Information

Store between 20°-25°C (68°-77°F)

Inactive Ingredients

caprylic/capric triglyceride, caprytyl glycol, ceteareth-20, chamomillia recutitia flower extract, citric acid, glycerin, glyceryl, stearate, palmitic acid. petrolatum phenoxyethanol, stearic acid, purified water

Questions Or Comments?

Call 908 630 9445 weekdays 9:00am to 4:30pm EST or visit us online at www.exederm.com

When Using This Product
  • Avoid contact with the eyes
  • Do not begin use 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
Children Under 2 Years of Age

Do not use. Consult a doctor.

Adults and Children 2 Years and Older

Apply to the affected area not more than 3 to 4 times daily.

Principal Display Panel 2 Oz Carton Label

NDC 47832-205-34

exederm ®

flare control cream

for eczema & dermatitis

NET WT 2 OZ (56g)

1% Hydrocortisone Anti-Itch Cream


Structured Label Content

Uses:

For temporary relief of itching associated with minor skin irritation, inflammation 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)

Drug Facts

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 1.0% w/w

Other Information

Store between 20°-25°C (68°-77°F)

Inactive Ingredients

caprylic/capric triglyceride, caprytyl glycol, ceteareth-20, chamomillia recutitia flower extract, citric acid, glycerin, glyceryl, stearate, palmitic acid. petrolatum phenoxyethanol, stearic acid, purified water

Questions Or Comments? (Questions or comments?)

Call 908 630 9445 weekdays 9:00am to 4:30pm EST or visit us online at www.exederm.com

When Using This Product (When using this product)
  • Avoid contact with the eyes
  • Do not begin use 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
Children Under 2 Years of Age (Children under 2 years of age)

Do not use. Consult a doctor.

Adults and Children 2 Years and Older (Adults and children 2 years and older)

Apply to the affected area not more than 3 to 4 times daily.

Principal Display Panel 2 Oz Carton Label (Principal Display Panel - 2 oz Carton Label)

NDC 47832-205-34

exederm ®

flare control cream

for eczema & dermatitis

NET WT 2 OZ (56g)

1% Hydrocortisone Anti-Itch Cream


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)