Hydrocortisone Cream With Aloe Maximum Strength - Major

Hydrocortisone Cream With Aloe Maximum Strength - Major
SPL v5
SPL
SPL Set ID 576fe736-cf19-4945-93c0-143d5fc98cbc
Route
TOPICAL
Published
Effective Date 2021-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Cetyl Alcohol Glyceryl Monostearate Isopropyl Myristate Methylparaben Polyoxyl 40 Stearate Polysorbate 60 Propylene Glycol Propylparaben Water Sorbic Acid Sorbitan Monostearate Stearyl Alcohol White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2009-04-21

Description

Hydrocortisone, USP 1%

Purpose

Anti-itch

How Supplied

Product: 50090-3113 NDC: 50090-3113-0 28 g in a TUBE / 1 in a CARTON


Medication Information

Purpose

Anti-itch

How Supplied

Product: 50090-3113

NDC: 50090-3113-0 28 g in a TUBE / 1 in a CARTON

Description

Hydrocortisone, USP 1%

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
  • jewelry
  • detergents
  • cosmetics
  • psoriasis
  • seborrheic dermatitis
  • 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

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, consult a doctor

For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, 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

Do Not Use
  • for external feminine itching if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday–Friday.

Hydrocortisone
Active Ingredient

Hydrocortisone, USP 1%

Other Information
  • Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
  • Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive Ingredients

aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

When Using This Product
  • avoid contact with the eyes

  • do not begin the use of any other hydrocortisone product unless directed by a doctor

  • for external anal itching:

    • do not use more than directed unless directed by 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
  • symptoms last for more than 7 days
  • the condition gets worse
  • symptoms clear up and occur again in a few days
  • rectal bleeding occurs, consult doctor promptly
Keep Out of Reach of Children. 

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


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
  • jewelry
  • detergents
  • cosmetics
  • psoriasis
  • seborrheic dermatitis
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Purpose

Anti-itch

Warnings

For external use only

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, consult a doctor

For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, 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

Do Not Use (Do not use)
  • for external feminine itching if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday–Friday.

How Supplied (HOW SUPPLIED)

Product: 50090-3113

NDC: 50090-3113-0 28 g in a TUBE / 1 in a CARTON

Hydrocortisone
Active Ingredient (Active ingredient)

Hydrocortisone, USP 1%

Other Information (Other information)
  • Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
  • Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive Ingredients (Inactive ingredients)

aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

When Using This Product (When using this product)
  • avoid contact with the eyes

  • do not begin the use of any other hydrocortisone product unless directed by a doctor

  • for external anal itching:

    • do not use more than directed unless directed by 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)
  • symptoms last for more than 7 days
  • the condition gets worse
  • symptoms clear up and occur again in a few days
  • rectal bleeding occurs, consult doctor promptly
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.


Advanced Ingredient Data


Raw Label Data

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