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

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
  • 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

Purpose

Anti-itch

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

Other Information
  • store at room temperature, protect from freezing

Description

Hydrocortisone 1%

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

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%

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

Warnings

For external use only

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

Purpose

Anti-itch

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

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

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

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%

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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