091 Curad Hydrocortisone 1% Cream Anti-itch

091 Curad Hydrocortisone 1% Cream Anti-itch
SPL v13
SPL
SPL Set ID b0947381-c0db-4253-ab40-3d45603ae65d
Route
TOPICAL
Published
Effective Date 2023-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Methylchloroisothiazolinone/methylisothiazolinone Mixture Stearic Acid Trolamine White Petrolatum Water Cetostearyl Alcohol Propylene Glycol Glyceryl Monostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-03-01

Description

Hydrocortisone 1%, USP

Purpose

Antipuritic (Anti Itch)


Medication Information

Purpose

Antipuritic (Anti Itch)

Description

Hydrocortisone 1%, USP

Uses
  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, scrapes
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Warnings
  • for external use only
  • avoid contact with eyes
Directions
  • For 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.

For external anal itching,

  • Adults: When practical, cleanse the affected area with mild soap and 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.
Package Label

Other Information
  • Store at controlled room temperature 68°-77° F (20°-25° C).
  • Use only if package is intact.
Inactive Ingredients

cetostearyl alcohol, glyceryl monostearate SE, kathon CG, propylene glycol, purified water, stearic acid, trolamine, white petrolatum.

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in India

www.curad.com

1-800-633-5463

REF: CUR015431

V2 RA23GZP

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use and Consult A Doctor
  • for the treatment of diaper rash
  • if you have a vaginal discharge
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Do not exceed the recommended daily dosage unless directed by the doctor. In case of bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Active Ingredient (in Each Gram)

Hydrocortisone 1%, USP


Structured Label Content

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

Antipuritic (Anti Itch)

Warnings
  • for external use only
  • avoid contact with eyes
Directions
  • For 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.

For external anal itching,

  • Adults: When practical, cleanse the affected area with mild soap and 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.
Package Label

Other Information (Other information)
  • Store at controlled room temperature 68°-77° F (20°-25° C).
  • Use only if package is intact.
Inactive Ingredients (Inactive ingredients)

cetostearyl alcohol, glyceryl monostearate SE, kathon CG, propylene glycol, purified water, stearic acid, trolamine, white petrolatum.

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in India

www.curad.com

1-800-633-5463

REF: CUR015431

V2 RA23GZP

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.

Do Not Use and Consult A Doctor (Do not use and consult a doctor)
  • for the treatment of diaper rash
  • if you have a vaginal discharge
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Do not exceed the recommended daily dosage unless directed by the doctor. In case of bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Active Ingredient (in Each Gram) (Active ingredient (in each gram))

Hydrocortisone 1%, USP


Advanced Ingredient Data


Raw Label Data

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