SPL v3
SPL
SPL Set ID 26a29de3-4b79-4a3a-93b6-a14c5e91a8c6
Route
TOPICAL
Published
Effective Date 2022-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Aluminum Sulfate Yellow Wax Calcium Acetate Cetostearyl Alcohol Maltodextrin Glycerin Methylparaben Mineral Oil Petrolatum Propylparaben Sodium Cetostearyl Sulfate Sodium Laureth Sulfate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-30

Description

Hydrocortisone 1.0%

Purpose

Anti-Itch 


Medication Information

Purpose

Anti-Itch 

Description

Hydrocortisone 1.0%

Uses

For 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
  • external feminine, genital and anal itching.

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

Section 50565-1

Keep this and all drugs out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Purpose 

Anti-Itch 

Directions

  • Adults and children 2 years and older
  • apply to affected area not more than 3 to 4 times daily.
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.
Warnings 

For external use only

Active Ingredient 

Hydrocortisone 1.0%

Inactive Ingredient

 Aloe Barbadensis Leaf Juice, Aluminum Sulfate, Beeswax, Calcium Acetate, Cetearyl Alcohol, Dextrin, Glycerin, Maltodextrin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Purified Water

When Using This Product 
  • avoid contact with eyes
  • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, 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
  • If condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
Principal Display Panel Tube 

  WINCO                                                    NDC 67091-055-28

MAXIMUM STRENGTH

HYDROCORTISONE CREAM with aloe 

Hydrocortisone 1%

NET WT. 1 OZ (28G) 

Principal Display Panel Carton 

WINCO NDC 67091-055-28

MAXIMUM STRENGTH

HYDROCORTISONE CREAM with aloe

Hydrocortisone 1%

NET WT. 1 OZ (28G)


Structured Label Content

Uses

For 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
  • external feminine, genital and anal itching.

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

Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Purpose 

Anti-Itch 

Directions

  • Adults and children 2 years and older
  • apply to affected area not more than 3 to 4 times daily.
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.
Warnings 

For external use only

Active Ingredient 

Hydrocortisone 1.0%

Inactive Ingredient (INACTIVE INGREDIENT)

 Aloe Barbadensis Leaf Juice, Aluminum Sulfate, Beeswax, Calcium Acetate, Cetearyl Alcohol, Dextrin, Glycerin, Maltodextrin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Purified Water

When Using This Product  (When using this product )
  • avoid contact with eyes
  • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, 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)
  • If condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
Principal Display Panel Tube  (Principal Display panel-Tube )

  WINCO                                                    NDC 67091-055-28

MAXIMUM STRENGTH

HYDROCORTISONE CREAM with aloe 

Hydrocortisone 1%

NET WT. 1 OZ (28G) 

Principal Display Panel Carton  (Principal Display Panel - Carton )

WINCO NDC 67091-055-28

MAXIMUM STRENGTH

HYDROCORTISONE CREAM with aloe

Hydrocortisone 1%

NET WT. 1 OZ (28G)


Advanced Ingredient Data


Raw Label Data

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