Family Wellness Max Strength 1% Hydrocortisone Cream

Family Wellness Max Strength 1% Hydrocortisone Cream
SPL v3
SPL
SPL Set ID bca5ac2c-45cd-44e3-98f1-317a04e44d7d
Route
TOPICAL
Published
Effective Date 2023-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Cetyl Alcohol Edetate Disodium Anhydrous Glyceryl Monostearate Methylparaben Mineral Oil Petrolatum Polysorbate 60 Propylene Glycol Propylparaben Water Sorbitan Monostearate

Identifiers & Packaging

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

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses

• temporarily relieves 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 • temporarily relieves external anal and genital itching • other uses of this product should be under advice and supervision of a doctor

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 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.
Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Active Ingredient

Hydrocortisone 1%

Package Labeling:

Other Info Rmation
  • store at room temperature68°-77°F(20°-25°C).
  • tamper-evident: do not use if foil seal is broken or missing.
Inactive Ingredients

aloe barbadensis leaf juice, cetyl alcohol, disodium EDTA, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate

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 fngers or any mechanical device or applicator
Stop Use and Ask A Doctor If
  • condition worsens, symptoms persists 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
Keep Out of Reach of Children

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


Structured Label Content

Uses

• temporarily relieves 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 • temporarily relieves external anal and genital itching • other uses of this product should be under advice and supervision of a doctor

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 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.
Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Package Labeling:

Other Info Rmation (Other info rmation)
  • store at room temperature68°-77°F(20°-25°C).
  • tamper-evident: do not use if foil seal is broken or missing.
Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, cetyl alcohol, disodium EDTA, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate

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 fngers or any mechanical device or applicator
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, symptoms persists 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
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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