Gopaldas (as Cmo) - Sofskin Hydrocortisone Cream 1% (61040-129)

Gopaldas (as Cmo) - Sofskin Hydrocortisone Cream 1% (61040-129)
SPL v1
SPL
SPL Set ID 28ed3770-890f-e480-e063-6294a90af4f8
Route
TOPICAL
Published
Effective Date 2024-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Cetostearyl Alcohol Aloe Vera Leaf White Petrolatum Glyceryl Stearate Se Water Stearic Acid Trolamine Methylchloroisothiazolinone/methylisothiazolinone Mixture Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-15

Description

HYDROCORTISONE 1%

Purpose

Antipruritic (Anti-Itch)


Medication Information

Purpose

Antipruritic (Anti-Itch)

Description

HYDROCORTISONE 1%

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy
  • poison oak
  • poison 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 50565-1

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

Section 51945-4

Warnings
  • For external use only.

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.

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

Directions
  • for itching or 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

Other Information
  • do not use if seal on the tube is damaged or is not visible
  • to open, unscrew cap, pull tab to remove foil seal
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat and humidity
  • see crimp of tube or carton for Lot Number and Expiry Date
Active Ingredients

HYDROCORTISONE 1%

Inactive Ingredient

Aloe Vera Extract, Cetostearyl Alcohol, Glyceryl Monostearate SE, Kathon CG, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum


Structured Label Content

Uses (USES)
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy
  • poison oak
  • poison 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 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Antipruritic (Anti-Itch)

Warnings (WARNINGS)
  • For external use only.

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.

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

Directions (DIRECTIONS)
  • for itching or 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

Other Information (OTHER INFORMATION)
  • do not use if seal on the tube is damaged or is not visible
  • to open, unscrew cap, pull tab to remove foil seal
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat and humidity
  • see crimp of tube or carton for Lot Number and Expiry Date
Active Ingredients (ACTIVE INGREDIENTS)

HYDROCORTISONE 1%

Inactive Ingredient (INACTIVE INGREDIENT)

Aloe Vera Extract, Cetostearyl Alcohol, Glyceryl Monostearate SE, Kathon CG, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum


Advanced Ingredient Data


Raw Label Data

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