hydrocortisone ½%

hydrocortisone ½%
SPL v4
SPL
SPL Set ID 2ada9ec2-1c28-4da2-8639-07b3193ffb32
Route
topical
Published
Effective Date 2020-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (0.5 g)
Inactive Ingredients
cetostearyl alcohol citric acid monohydrate glycerin glyceryl monostearate methylparaben mineral oil paraffin propylparaben water sodium cetostearyl sulfate sodium lauryl sulfate stearyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2001-09-13

Purpose

Anti-itch cream

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses
  • temporary relief of itching associated with minor skin irritations and rashes due to
    • eczema
    • insect bites
    • poison ivy, poison oak, or poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • external genital and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Purpose

Anti-itch cream

Directions

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: do not use. consult a doctor

Other Information
  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

aloe barbadensis, cetostearyl alcohol, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol

Description

Drug Facts

Questions?

Call 1-866-923-4914

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this productconsult a doctor before exceeding recommended dosage

Do Not Use
  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator
Active Ingredient

Hydrocortisone 0.5%

For External Anal Itching:
  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Stop Use and Ask A Doctor If
  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.
Ask A Doctor Before Use If You Have
  • a vaginal discharge
  • rectal bleeding
  • diaper rash
Principal Display Panel 28.4 G Tube Carton

Itch and Rash Relief

Sensitive Skin

Hydrocortisone ½%

Cream

Antipruritic (Anti-Itch)

With Aloe

NET WT 1 oz (28.4 g)


Structured Label Content

Warnings

For external use only

Uses
  • temporary relief of itching associated with minor skin irritations and rashes due to
    • eczema
    • insect bites
    • poison ivy, poison oak, or poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • external genital and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Purpose

Anti-itch cream

Directions

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: do not use. consult a doctor

Other Information (Other information)
  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

aloe barbadensis, cetostearyl alcohol, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol

Questions?

Call 1-866-923-4914

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this productconsult a doctor before exceeding recommended dosage

Do Not Use (Do not use)
  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator
Active Ingredient (Active ingredient)

Hydrocortisone 0.5%

For External Anal Itching: (For external anal itching:)
  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a vaginal discharge
  • rectal bleeding
  • diaper rash
Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

Itch and Rash Relief

Sensitive Skin

Hydrocortisone ½%

Cream

Antipruritic (Anti-Itch)

With Aloe

NET WT 1 oz (28.4 g)


Advanced Ingredient Data


Raw Label Data

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