Thera Plus Maximum Strength Hydrocortisone Cream

Thera Plus Maximum Strength Hydrocortisone Cream
SPL v1
SPL
SPL Set ID 7d4e21d1-2914-4690-9084-a52abeab0958
Route
TOPICAL
Published
Effective Date 2025-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Ceteareth-20 Cetearyl Alcohol Ethylhexylglycerin Glycerin Glyceryl Stearate Mineral Oil Phenoxyethanol Water White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-20

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 gential 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: do not use, 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.

Drug Facts

Questions?

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

Active Ingredient

Hydrocortisone 1%

Other Information

• store at room temperature 68 °- 77° F (20°-25°C).

Package Labeling:

Inactive Ingredients

ceteareth-20, cetearyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, phenoxyethanol, water, white petrolatum

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 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 (1-800-222-1222).


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 gential 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: do not use, 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.

Drug Facts

Questions?

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

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)

• store at room temperature 68 °- 77° F (20°-25°C).

Package Labeling:

Inactive Ingredients (Inactive ingredients)

ceteareth-20, cetearyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, phenoxyethanol, water, white petrolatum

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 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 (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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