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

Purpose

Anti-itch

Description

Hydrocortisone 1%


Medication Information

Warnings

For external use only

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
Purpose

Anti-itch

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

Hydrocortisone 1%

Section 51945-4

Hydrocortisone

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%

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

Warnings

For external use only

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
Purpose

Anti-itch

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
Other Information (Other information)
  • store at 20 to 25 oC (68 to 77 oF)
Section 51945-4 (51945-4)

Hydrocortisone

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%

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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