Cortizone 10 Water Resistant Ointment

Cortizone 10 Water Resistant Ointment
SPL v4
SPL
SPL Set ID 118e55e7-241f-44c4-959e-09bf6221bd77
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Cortizone 10 Ointment Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Cortizone 10 Ointment Drug Facts

Use

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

    eczema  psoriasispoison ivy, oak, sumac  insect bites  detergents  jewelry   cosmetics

      soaps  seborrheic dermatitis

 temporarily relieves external anal and genital itching

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

Keep

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

Section 42229-5

Cortizone 10

Ointment

Drug Facts

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 time daily

    • children under 2 years of age: do not use, 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.

Active Ingredient

Hydrocortisone 1%

Inactive Ingredients

petrolatum

Principal Display Panel

Cortizone 10

WATER RESISTANT OINTMENT

1% Hydrocortisone

Anti-Itch Ointment

Net wt 1 oz (28 g)

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


Structured Label Content

Use

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

    eczema  psoriasispoison ivy, oak, sumac  insect bites  detergents  jewelry   cosmetics

      soaps  seborrheic dermatitis

 temporarily relieves external anal and genital itching

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

Keep

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

Section 42229-5 (42229-5)

Cortizone 10

Ointment

Drug Facts

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 time daily

    • children under 2 years of age: do not use, 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.

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Inactive Ingredients (Inactive ingredients)

petrolatum

Principal Display Panel

Cortizone 10

WATER RESISTANT OINTMENT

1% Hydrocortisone

Anti-Itch Ointment

Net wt 1 oz (28 g)

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


Advanced Ingredient Data


Raw Label Data

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