Hydrocortisone Cream 1% With Aloe

Hydrocortisone Cream 1% With Aloe
SPL v2
SPL
SPL Set ID 312ddc8d-100e-cfac-e063-6294a90acd09
Route
TOPICAL
Published
Effective Date 2025-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-26

Description

Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Drug Facts

Uses
  • temporarily relieves 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
  • temporarily relieves external anal and genital itching
  • other uses of this product should be only under the advice and supervision of a doctor
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only

Directions
  • for itching of 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
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.
Active Ingredient

Hydrocortisone 1%

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 room temperature 68-77°F (20°-25°C)
  • see crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients

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

Questions Or Comments?

Call 1-866-923-4914

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
Principal Display Panel 28.4 G Carton

MAXIMUM STRENGTH

Hydrocortisone Cream 1%

Soothing Aloe Cream

NET WT 1 oz (28.4 g)


Structured Label Content

Uses
  • temporarily relieves 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
  • temporarily relieves external anal and genital itching
  • other uses of this product should be only under the advice and supervision of a doctor
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anti-itch

Warnings

For external use only

Directions
  • for itching of 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
Do Not Use (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.
Active Ingredient (Active ingredient)

Hydrocortisone 1%

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 room temperature 68-77°F (20°-25°C)
  • see crimp of tube or carton for Lot Number and Expiry Date
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or Comments?)

Call 1-866-923-4914

When Using This Product (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 (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
Principal Display Panel 28.4 G Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Carton)

MAXIMUM STRENGTH

Hydrocortisone Cream 1%

Soothing Aloe Cream

NET WT 1 oz (28.4 g)


Advanced Ingredient Data


Raw Label Data

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