Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID e58f6b3a-c077-4a99-8f18-94884cca3f74
Route
TOPICAL
Published
Effective Date 2013-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Cetyl Alcohol Butylated Hydroxytoluene Glycerin Glyceryl Monostearate Isopropyl Myristate Methylparaben Squalane Stearic Acid Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-11-15

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses
  • temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to:
  • eczema
  • insect bites
  • poison ivy, oak, or sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Section 51945-4

Hydrocortisone

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 times daily
  • children under 2 years: Ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and 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
Active Ingredient

Hydrocortisone 1%

Other Information
  • store at 20 to 25 oC (68 to 77 oF)
Inactive Ingredient

Butylated hydroxytoluene, Cetyl alcohol, Glycerin, Glyceryl monostearate, Isopropyl myristate, Methylparaben, Propylparaben, Purified water, Squalane and Stearic acid

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 us 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 right away.


Structured Label Content

Uses
  • temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to:
  • eczema
  • insect bites
  • poison ivy, oak, or sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor
Section 51945-4 (51945-4)

Hydrocortisone

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 times daily
  • children under 2 years: Ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and 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
Active Ingredient

Hydrocortisone 1%

Other Information (Other information)
  • store at 20 to 25 oC (68 to 77 oF)
Inactive Ingredient

Butylated hydroxytoluene, Cetyl alcohol, Glycerin, Glyceryl monostearate, Isopropyl myristate, Methylparaben, Propylparaben, Purified water, Squalane and Stearic acid

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 us 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 right away.


Advanced Ingredient Data


Raw Label Data

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