Anti Itch

Anti Itch
SPL v1
SPL
SPL Set ID 2fa74baf-e3d2-e099-e063-6394a90a1bae
Route
TOPICAL
Published
Effective Date 2025-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Anhydrous Citric Acid Water Poloxamer 407 Edetate Disodium Alcohol Glycerin Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-06

Description

Hydrocortisone 1.0%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1.0%

Uses

Temporarily alleviates itching associated with minor skin irritation, inflammation and rashes due to:

  • Eczema
  • Poison ivy, oak and sumac
  • Psoriasis
  • Soaps and detergents
  • Cosmetics
  • Jewelry
  • Insect bites
  • Seborheic dermatitis
Section 51945-4

Warnings

For external use only.

Flammable: Do not use while smoking or near heat or flame

Directions:

Shake well

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: ask a doctor - to apply to face, spray into palm of hand and gently apply

Inactive Ingredients:

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 407, Polysorbate 20, SD Alcohol 40-B, USP grade purified Water.

Warnings : Do Not Use:

In or near the eyes; for diaper rash ask a doctor. In case of an accidental exposure rinse with water or saline immediately, remove contact lenses and sesk medical help for any persistent symptoms. Use only as directed. Do not puncture or incinerate. Contents under pressure. Avoid long term storage above 104°F. Do not store at temperatures above 120°F.

Drug Facts Active Ingredient

Hydrocortisone 1.0%

Warnings : Stop Use and Ask Doctor

if condition worsens or does not improve within 7 days, or clears up and occurs again within a few days.

Warnings : Ask A Doctor Before Use If

you are using any other hydrocortisone or corticosteroid product.

Warnings: Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center right away. 1-800-222-1222


Structured Label Content

Uses

Temporarily alleviates itching associated with minor skin irritation, inflammation and rashes due to:

  • Eczema
  • Poison ivy, oak and sumac
  • Psoriasis
  • Soaps and detergents
  • Cosmetics
  • Jewelry
  • Insect bites
  • Seborheic dermatitis
Section 51945-4 (51945-4)

Purpose

Anti-Itch

Warnings

For external use only.

Flammable: Do not use while smoking or near heat or flame

Directions:

Shake well

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: ask a doctor - to apply to face, spray into palm of hand and gently apply

Inactive Ingredients: (Inactive ingredients:)

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 407, Polysorbate 20, SD Alcohol 40-B, USP grade purified Water.

Warnings : Do Not Use: (Warnings : Do not use:)

In or near the eyes; for diaper rash ask a doctor. In case of an accidental exposure rinse with water or saline immediately, remove contact lenses and sesk medical help for any persistent symptoms. Use only as directed. Do not puncture or incinerate. Contents under pressure. Avoid long term storage above 104°F. Do not store at temperatures above 120°F.

Drug Facts Active Ingredient (DRUG FACTS - Active Ingredient)

Hydrocortisone 1.0%

Warnings : Stop Use and Ask Doctor (Warnings : Stop use and ask doctor)

if condition worsens or does not improve within 7 days, or clears up and occurs again within a few days.

Warnings : Ask A Doctor Before Use If (Warnings : Ask a doctor before use if)

you are using any other hydrocortisone or corticosteroid product.

Warnings: Keep Out of Reach of Children (Warnings: Keep out of reach of children)

If swallowed, get medical help or contact a poison control center right away. 1-800-222-1222


Advanced Ingredient Data


Raw Label Data

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