Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID ea656cf8-cad5-4fa5-82e7-daec77a0bb04
Route
TOPICAL
Published
Effective Date 2024-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Propylene Glycol Petrolatum Mineral Oil Cetostearyl Alcohol Ceteth-20 Chlorocresol Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-11 Until 2027-01-01

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, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, external itching and anal itching.

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

Section 51727-6

Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, White Soft Paraffin

Section 51945-4

Warnings

For external use only

Do not use:

For the treatment of diaper rash.  Ask a doctor

In the genital if you have a 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

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

Directions

for itching of skin irritation, inflammation and rashes:

  • Adults and children 2 years of age and olderapply 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:

  • adults: 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: ask 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 immediately.


Structured Label Content

Uses

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

eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, external itching and anal itching.

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

Section 51727-6 (51727-6)

Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, White Soft Paraffin

Section 51945-4 (51945-4)

Purpose

Anti-Itch

Warnings

For external use only

Do not use:

For the treatment of diaper rash.  Ask a doctor

In the genital if you have a 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

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

Directions

for itching of skin irritation, inflammation and rashes:

  • Adults and children 2 years of age and olderapply 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:

  • adults: 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: ask 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 immediately.


Advanced Ingredient Data


Raw Label Data

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