Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID aaf91c65-8460-49a6-a331-582b3fb6cdce
Route
TOPICAL
Published
Effective Date 2010-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 h)
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 2010-09-01

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
  • psoriasis
  • seborrheic dermatitis
  • poison ivy, oak, sumac
  • insect bites
  • soaps and detergents
  • cosmetics
  • jewelry
  • external feminine and anal itching
Other uses of this product:  ask a doctor

Section 51727-6

Cetyl alcohol, Butylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myristoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water

Section 51945-4

Hydrocortisone

Warnings

For external use only

Directions
  • apply to affected area not more than 3 to 4 times daily
  • for external anal itching:  when practical, clean area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 2 years, or children under 12 years with external anal itching:  do not use, ask a doctor

Do Not Use
  • in or near the eyes
  • by putting directly into the rectum by using fingers or any mechanical device or applicator
  • for external feminine itching if you have a vaginal discharge
  • for diaper rash; ask a doctor

Active Ingredient

Hydrocortisone 1%

Other Information
  • store at room temperature, protect from freezing

When Using This Product

for external anal itching, do not exceed recommended daily dosage unless directed by a doctor

Stop Use and Ask A Doctor If
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • rectal bleeding occurs

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control

Ask A Doctor Or Pharmacist Before Use If You Are

using any other hydrocortisone product


Structured Label Content

Uses

temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to:

  • eczema
  • psoriasis
  • seborrheic dermatitis
  • poison ivy, oak, sumac
  • insect bites
  • soaps and detergents
  • cosmetics
  • jewelry
  • external feminine and anal itching
Other uses of this product:  ask a doctor

Section 51727-6 (51727-6)

Cetyl alcohol, Butylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myristoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water

Section 51945-4 (51945-4)

Hydrocortisone

Purpose

Anti-itch

Warnings

For external use only

Directions
  • apply to affected area not more than 3 to 4 times daily
  • for external anal itching:  when practical, clean area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 2 years, or children under 12 years with external anal itching:  do not use, ask a doctor

Do Not Use (Do not use)
  • in or near the eyes
  • by putting directly into the rectum by using fingers or any mechanical device or applicator
  • for external feminine itching if you have a vaginal discharge
  • for diaper rash; ask a doctor

Active Ingredient

Hydrocortisone 1%

Other Information (Other information)
  • store at room temperature, protect from freezing

When Using This Product (When using this product)

for external anal itching, do not exceed recommended daily dosage unless directed by a doctor

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • 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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

using any other hydrocortisone product


Advanced Ingredient Data


Raw Label Data

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