Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID cfefb517-9099-41c4-8a95-74414ca4032c
Route
TOPICAL
Published
Effective Date 2024-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Alcohol Aloe Vera Leaf Oat Carboxymethylcellulose Sodium, Unspecified Citric Acid Monohydrate Edetate Disodium Diethylene Glycol Monoethyl Ether Glycerin Maltodextrin Menthyl Lactate, (-)- Methyl Gluceth-20 Polyethylene Glycol 400 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-16

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
  • seborrheic dermatitis
  • other uses of this product should be only under advice and supervision of a doctor
Section 42229-5

Children under 2 years of age: do not use, ask a doctor

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

Flammable: Keep away from fire or flame and heated surfaces

Do Not Use
  • for the treatment of diaper rash. Consult a doctor.
  • if you are allergic to any ingredient in the product
Active Ingredient

Hydrocortisone 1%

Other Information

store in a cool place away from direct sunlight store with cap closed tightly

Inactive Ingredients

Alcohol Denat. (45%), Aloe Barbadensis Leaf Juice, Avena Sativa Kernel Extract, Carboxymethylcellulose, Citric Acid, Disodium EDTA, Ethoxydiglycol, Glycerin, Maltodextrin, Menthyl Lactate, Methyl Gluceth-20, PEG-8, Water.

When Using This Product
  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
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, do not use this or any other hydrocortisone product unless you have asked a doctor
Adults and Children 2 Years of Age and Over:
  • apply to affected area by placing applicator on skin, press firmly and hold to activate the dispensing of liquid. Do not use more than 3 to 4 times daily.
Principal Display Panel – 36 Ml Carton Label

Walgreens

WALGREENS • PHARMACIST RECOMMENDED

Compare to the active ingredient in

Cortizone-10
® Maximum Strength

Anti-Itch Liquid With Aloe††

NO MESS

Hydrocortisone

Applicator

HYDROCORTISONE 1% / ANTI-ITCH

+ Aloe

Fast Itch Relief

  • Maximum Strength without

    a prescription*
  • Relieves itch associated

    with rashes, inflammation,

    & minor skin irritations

1

APPLICATOR

1.25 FL OZ (36 mL)

Aloe

NOT ACTUAL SIZE


Structured Label Content

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
  • seborrheic dermatitis
  • other uses of this product should be only under advice and supervision of a doctor
Section 42229-5 (42229-5)

Children under 2 years of age: do not use, ask a doctor

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

Flammable: Keep away from fire or flame and heated surfaces

Do Not Use (Do not use)
  • for the treatment of diaper rash. Consult a doctor.
  • if you are allergic to any ingredient in the product
Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)

store in a cool place away from direct sunlight store with cap closed tightly

Inactive Ingredients (Inactive ingredients)

Alcohol Denat. (45%), Aloe Barbadensis Leaf Juice, Avena Sativa Kernel Extract, Carboxymethylcellulose, Citric Acid, Disodium EDTA, Ethoxydiglycol, Glycerin, Maltodextrin, Menthyl Lactate, Methyl Gluceth-20, PEG-8, Water.

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
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, do not use this or any other hydrocortisone product unless you have asked a doctor
Adults and Children 2 Years of Age and Over: (Adults and children 2 years of age and over:)
  • apply to affected area by placing applicator on skin, press firmly and hold to activate the dispensing of liquid. Do not use more than 3 to 4 times daily.
Principal Display Panel – 36 Ml Carton Label (Principal Display Panel – 36 mL Carton Label)

Walgreens

WALGREENS • PHARMACIST RECOMMENDED

Compare to the active ingredient in

Cortizone-10
® Maximum Strength

Anti-Itch Liquid With Aloe††

NO MESS

Hydrocortisone

Applicator

HYDROCORTISONE 1% / ANTI-ITCH

+ Aloe

Fast Itch Relief

  • Maximum Strength without

    a prescription*
  • Relieves itch associated

    with rashes, inflammation,

    & minor skin irritations

1

APPLICATOR

1.25 FL OZ (36 mL)

Aloe

NOT ACTUAL SIZE


Advanced Ingredient Data


Raw Label Data

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