Topco Associates Llc. Hydrocortisone 1% Cream Drug Facts

Topco Associates Llc. Hydrocortisone 1% Cream Drug Facts
SPL v5
SPL
SPL Set ID 858053a0-d888-4bb9-b94e-503bcf3864cb
Route
TOPICAL
Published
Effective Date 2024-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Water Cetostearyl Alcohol Cetyl Palmitate Glycerin Isopropyl Myristate Isostearyl Neopentanoate Polyoxyl 20 Cetostearyl Ether Diazolidinyl Urea Sorbic Acid Aloe Vera Leaf Butylated Hydroxytoluene Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-14

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

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
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: do not use, 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.
Active Ingredient

Hydrocortisone 1%

Other Information
  • store at 20-25°C (68-77°F)
Inactive Ingredients

water, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, ceteareth-20, diazolidinyl urea, sorbic acid, aloe barbadensis leaf juice, BHT, sodium hydroxide

Questions Or Comments?

1-888-423-0139

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 use this or any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Package/label Principal Display Panel

COMPARE TO MAXIMUM STRENGTH CORTIZONE • 10® ACTIVE INGREDIENT

Relieves Itch Fast with Aloe

Effective Relief of Skin Irritation, Rashes, Inflammation, Itching & Redness

TopCare® health

MAXIMUM STRENGTH

Hydrocortisone 1% Cream

ANTI-ITCH CREAM

with Aloe

NET WT 1 OZ (28 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
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: do not use, 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.
Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

water, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, ceteareth-20, diazolidinyl urea, sorbic acid, aloe barbadensis leaf juice, BHT, sodium hydroxide

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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 use this or any other hydrocortisone product unless you have asked a doctor
  • 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 Center right away (1-800-222-1222).

Package/label Principal Display Panel (Package/Label Principal Display Panel)

COMPARE TO MAXIMUM STRENGTH CORTIZONE • 10® ACTIVE INGREDIENT

Relieves Itch Fast with Aloe

Effective Relief of Skin Irritation, Rashes, Inflammation, Itching & Redness

TopCare® health

MAXIMUM STRENGTH

Hydrocortisone 1% Cream

ANTI-ITCH CREAM

with Aloe

NET WT 1 OZ (28 g)


Advanced Ingredient Data


Raw Label Data

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