Equate Hydrocortisone Cream

Equate Hydrocortisone Cream
SPL v4
SPL
SPL Set ID 85b7f620-cc95-4333-b124-bbcc8fd5f7eb
Route
TOPICAL
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Cetostearyl Alcohol Petrolatum Phenoxyethanol Propylene Glycol Sodium Lauryl Sulfate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-31

Description

Hydrocortisone Acetate 1%

Purpose

Anti itch 


Medication Information

Purpose

Anti itch 

Description

Hydrocortisone Acetate 1%

Uses

For temporarily relief of 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

Other uses of this product should only be under the advice and supervision of a doctor

Purpose 

Anti itch 

Drug Fact 

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, ask a doctor
  • For external anal itching ; adults ;when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.Children under 12 years of age with external anal itching consult a doctor. 
Do Not Use 
  •  for the treatment of diaper rash. Consult a doctor.
  • for external genital itching if you have a vaginal discharge, consult a doctor. 
Active Ingredient 

Hydrocortisone Acetate 1%

Other Information 

store at a controlled room temperature 20-25°C (68-77 F)

Inactive Ingredients 

Cetearyl Alcohol, Petrolatum, Phenoxyethanol, Propylene Glycol, Sodium Lauryl Sulfate, Water (purified)

When Using This Product 
  • Avoid contact with the eyes
  • Do not begin the use of any other hydrocortisone products unless you have consulted a doctor. 
  • For genital, feminine and anal itching do not exceed the recommended daily dose unless directed by a doctor, in case of bleeding , stop use and consult a doctor
  • Do not put this product 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

Principal  Display Panel 1 Oz 

Equate          NDC 79903-211-01

Maximum Strength

Hydrocortisone Cream 1%

Paraben free/Anti-itch

NETWT 1 OZ ( 28g)

Keep Out of the Reach of Children 

If swallowed get medical help or contact a poison control center (1-800-222-1222) right away. 


Structured Label Content

Uses

For temporarily relief of 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

Other uses of this product should only be under the advice and supervision of a doctor

Purpose 

Anti itch 

Drug Fact 

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, ask a doctor
  • For external anal itching ; adults ;when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.Children under 12 years of age with external anal itching consult a doctor. 
Do Not Use  (Do not use )
  •  for the treatment of diaper rash. Consult a doctor.
  • for external genital itching if you have a vaginal discharge, consult a doctor. 
Active Ingredient 

Hydrocortisone Acetate 1%

Other Information  (Other information )

store at a controlled room temperature 20-25°C (68-77 F)

Inactive Ingredients  (Inactive ingredients )

Cetearyl Alcohol, Petrolatum, Phenoxyethanol, Propylene Glycol, Sodium Lauryl Sulfate, Water (purified)

When Using This Product  (When using this product )
  • Avoid contact with the eyes
  • Do not begin the use of any other hydrocortisone products unless you have consulted a doctor. 
  • For genital, feminine and anal itching do not exceed the recommended daily dose unless directed by a doctor, in case of bleeding , stop use and consult a doctor
  • Do not put this product 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

Principal  Display Panel 1 Oz  (Principal  Display Panel 1 oz )

Equate          NDC 79903-211-01

Maximum Strength

Hydrocortisone Cream 1%

Paraben free/Anti-itch

NETWT 1 OZ ( 28g)

Keep Out of the Reach of Children  (Keep out of the reach of children )

If swallowed get medical help or contact a poison control center (1-800-222-1222) right away. 


Advanced Ingredient Data


Raw Label Data

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