Theracare Hydrocortisone Cream

Theracare Hydrocortisone Cream
SPL v3
SPL
SPL Set ID 01cb7b47-2c3c-707d-e063-6294a90a5d97
Route
TOPICAL
Published
Effective Date 2023-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Cetostearyl Alcohol Glyceryl 1-stearate Polyoxyl 20 Cetostearyl Ether Mineral Oil White Petrolatum Glycerin Water Ethylhexylglycerin Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-01

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

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 only be under the advice and supervision of a doctor
Warnings

For external use only

Directions
  • for itching of skin irritation, inflammation, and rashes:
  • adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • for external anal and genital itching, adults and children 12 years of age and over:
    • 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: consult a physician
Do Not Use
  • in the genital area if you have a vaginal discharge.
  • for the treatment of diaper rash.
  • with any other hydrocortisone product unless you have asked a doctor
Inactive I



ceteareth-20, cetearyl alcohol, ethylhexylglycerin, glycerin, glyceryl 1-stearate, mineral oil, phenoxyethanol, water, white petrolatum

Active Ingredient

Hydrocortisone 1%

Other Information

Store at 20-25C (68-77F)

do not use if tube seal under cap is broken

When Using This Product
  • use only as directed
  • 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
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Theracare Hydrocortisone Cream


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 only be under the advice and supervision of a doctor
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 over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • for external anal and genital itching, adults and children 12 years of age and over:
    • 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: consult a physician
Do Not Use (Do not use)
  • in the genital area if you have a vaginal discharge.
  • for the treatment of diaper rash.
  • with any other hydrocortisone product unless you have asked a doctor
Inactive I



ceteareth-20, cetearyl alcohol, ethylhexylglycerin, glycerin, glyceryl 1-stearate, mineral oil, phenoxyethanol, water, white petrolatum

Active Ingredient

Hydrocortisone 1%

Other Information (Other information)

Store at 20-25C (68-77F)

do not use if tube seal under cap is broken

When Using This Product (When using this product)
  • use only as directed
  • 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
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Theracare Hydrocortisone Cream (TheraCare Hydrocortisone Cream)


Advanced Ingredient Data


Raw Label Data

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