SPL v1
SPL
SPL Set ID 37cdfabc-1fdb-246a-e063-6394a90a008a
Route
TOPICAL
Published
Effective Date 2025-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
White Petrolatum Propylene Glycol Water Ceteareth-20 Cetearyl Alcohol Chlorocresol Mineral Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-17

Description

Active Ingredient: Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Active Ingredient: Hydrocortisone 1%

Uses
  • For the temporary relief of itching associated with minor skin irritations, inflammaion, and rashes due to: eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, and for externam genital, feminine and anal itching
  • other uses of this product should be only used under the advise and supervision of a doctor
Section 51945-4

Warnings

Warnings

For external use only

Directions

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: do not use, consult a doctor

For external anal and genital itching:

Adults and children 12 years of age and older:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toiet tissue or a soft cloth before apply
  • apply to affected ara not more than 3 to 4 ties daily

Children under 12 years og age: consult a doctor

Do Not Use

Do not use

  • for the treatment of diaper rash, consult a doctor
  • if you have vaginal discharge, consult a doctor
Active Ingredient

Active Ingredient: Hydrocortisone 1%

Inactive Ingredients

Inactive Ingredients: Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

When Using This Product

When using this product

  • avoid contact with eyes
  • do not use more than directed unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
  • in case of bleeding, consult a doctor promptly
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
  • do not begin use of any other hydrocortisone products unless you have consulted a doctor
Keep Out of Reach of Children

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


Structured Label Content

Uses
  • For the temporary relief of itching associated with minor skin irritations, inflammaion, and rashes due to: eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, and for externam genital, feminine and anal itching
  • other uses of this product should be only used under the advise and supervision of a doctor
Section 51945-4 (51945-4)

Purpose

Anti-Itch

Warnings

Warnings

For external use only

Directions

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: do not use, consult a doctor

For external anal and genital itching:

Adults and children 12 years of age and older:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toiet tissue or a soft cloth before apply
  • apply to affected ara not more than 3 to 4 ties daily

Children under 12 years og age: consult a doctor

Do Not Use (Do not use)

Do not use

  • for the treatment of diaper rash, consult a doctor
  • if you have vaginal discharge, consult a doctor
Active Ingredient

Active Ingredient: Hydrocortisone 1%

Inactive Ingredients

Inactive Ingredients: Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

When Using This Product (When using this product)

When using this product

  • avoid contact with eyes
  • do not use more than directed unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator
  • in case of bleeding, consult a doctor promptly
Stop Use and Ask A Doctor If (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
  • do not begin use of any other hydrocortisone products unless you have consulted a doctor
Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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