Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID d04e473d-8bbc-475c-a0b1-ca5eed67fbc7
Route
TOPICAL
Published
Effective Date 2023-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.01 g)
Inactive Ingredients
Propylene Glycol White Petrolatum Mineral Oil Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Chlorocresol Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses
  • For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:   eczema, psoriasis, poison ivy, oak & sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soap as well as for external genital, geminine and anal itching
  • Other uses of this product should be only under the advice and supervision of a doctor
Section 51727-6

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

Section 51945-4

Warnings

For external use only

Do not use:

For the treatment of diaper rash.  Consult a doctor

if you have vaginal discharge.  Consult a doctor

When using this product:

Avoid contact with the eyes

Do not use more than directed unless told to do so by a doctor.

Do not put this product into the rectum by using fingers or any mechanical device or applicator

If rectal bleeding occurs, consult a doctor promptly

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.

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.  Ask 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 toliet 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 with external anal itching: consult a doctor.
Active Ingredient

Hydrocortisone 1%

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


Structured Label Content

Uses
  • For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:   eczema, psoriasis, poison ivy, oak & sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soap as well as for external genital, geminine and anal itching
  • Other uses of this product should be only under the advice and supervision of a doctor
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Purpose

Anti-Itch

Warnings

For external use only

Do not use:

For the treatment of diaper rash.  Consult a doctor

if you have vaginal discharge.  Consult a doctor

When using this product:

Avoid contact with the eyes

Do not use more than directed unless told to do so by a doctor.

Do not put this product into the rectum by using fingers or any mechanical device or applicator

If rectal bleeding occurs, consult a doctor promptly

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.

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.  Ask 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 toliet 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 with external anal itching: consult a doctor.
Active Ingredient

Hydrocortisone 1%

Keep Out of Reach of Children (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


Advanced Ingredient Data


Raw Label Data

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