Hydrocortisone

Hydrocortisone
SPL v2
SPL
SPL Set ID 9bac1869-8072-49bd-8568-a87a184d2200
Route
TOPICAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Medium-chain Triglycerides Methylparaben Propylparaben Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-05

Description

Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Drug Facts

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • 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

Directions
  • for itching of skin irritation, inflammation, and rashes:
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • for external anal and genital itching, adults:
    • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
Do Not Use
  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Questions?

call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Active Ingredient

Hydrocortisone 1%

Other Information
  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

fractionated coconut oil, methylparaben, propylparaben, white petrolatum

When Using This Product
  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs
Principal Display Panel 28.4 G Tube Carton

Foster & Thrive™

MAXIMUM STRENGTH

Itch Relief Ointment

Hydrocortisone Ointment 1%

ANTI-ITCH

NET WT 1 OZ (28.4 g)


Structured Label Content

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • 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

Directions
  • for itching of skin irritation, inflammation, and rashes:
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • for external anal and genital itching, adults:
    • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
Do Not Use (Do not use)
  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Questions?

call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)
  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

fractionated coconut oil, methylparaben, propylparaben, white petrolatum

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
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, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs
Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

Foster & Thrive™

MAXIMUM STRENGTH

Itch Relief Ointment

Hydrocortisone Ointment 1%

ANTI-ITCH

NET WT 1 OZ (28.4 g)


Advanced Ingredient Data


Raw Label Data

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