Itch Relief Cream

Itch Relief Cream
SPL v2
SPL
SPL Set ID ae4b7cd6-8b5d-4d25-86f9-72260638bb94
Route
TOPICAL
Published
Effective Date 2024-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Cetostearyl Alcohol Sodium Lauryl Sulfate Sodium Cetostearyl Sulfate Chamomile Flower Oil Citric Acid Monohydrate Corn Oil Glycerin Glyceryl Monostearate Isopropyl Palmitate Maltodextrin Methylparaben Mineral Oil Paraffin Petrolatum Propylene Glycol Propylparaben Water Stearyl Alcohol Vitamin A .alpha.-tocopherol Cholecalciferol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-10

Description

Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Drug Facts

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

Warnings

For external use only

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 of age: ask a doctor
  • for external anal and genital itching, adults:
    • when practical, clean 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 applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
Do Not Use
  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Questions?

call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Active Ingredient

Hydrocortisone 1%

Other Information
  • to open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at 20° to 25° C (68° to 77° F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

aloe powder, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile oil, citric acid, corn oil, glycerin, glyceryl monostearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin wax, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A & vitamin D3 liquid, vitamin E, white petrolatum.

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 use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs
Principal Display Panel 28.4 G Tube Carton

Foster & Thrive™

MAXIMUM STRENGTH + 12 MOISTURIZERS

Itch Relief Cream

Hydrocortisone Cream 1%

ANTI-ITCH

NET WT 1 OZ (28.4 g)


Structured Label Content

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

Purpose

Anti-itch

Warnings

For external use only

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 of age: ask a doctor
  • for external anal and genital itching, adults:
    • when practical, clean 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 applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
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. Consult a doctor.
Questions?

call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)
  • to open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at 20° to 25° C (68° to 77° F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

aloe powder, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile oil, citric acid, corn oil, glycerin, glyceryl monostearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin wax, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A & vitamin D3 liquid, vitamin E, white petrolatum.

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 use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs
Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

Foster & Thrive™

MAXIMUM STRENGTH + 12 MOISTURIZERS

Itch Relief Cream

Hydrocortisone Cream 1%

ANTI-ITCH

NET WT 1 OZ (28.4 g)


Advanced Ingredient Data


Raw Label Data

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