Thera Plus Eczema Cream 1% Hydrocortisone Anti-itch

Thera Plus Eczema Cream 1% Hydrocortisone Anti-itch
SPL v2
SPL
SPL Set ID 7c72217b-db9a-4573-9f14-4c11528fa452
Route
TOPICAL
Published
Effective Date 2024-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Isohexadecane Maltodextrin Methylparaben Petrolatum Phenoxyethanol Polysorbate 80 Propylene Glycol Sodium Citrate Stearic Acid Tocopherol Water Ginger Methyl Gluceth-20 Aloe Vera Leaf Cetyl Alcohol Dimethicone Edetic Acid Ethylparaben Glycerin Glyceryl Monostearate

Identifiers & Packaging

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

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: 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
Drug Facts

Questions?

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

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.
Other Information
  • store at room temperature 68 °- 77° F (20° - 25°C).
Package Labeling:

Active Ingredients

Hydrocortisone 1%

Inactive Ingredients

aloe barbadensis leaf juice, cetyl alcohol, dimethicone, EDTA, ethylparaben, glycerin, glyceryl monostearate, isohexadecane, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 80, propylene glycol, sodium citrate, stearic acid, tocopherol, water, zingiber officinale (ginger) root extract

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 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: 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
Drug Facts

Questions?

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

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.
Other Information (Other information)
  • store at room temperature 68 °- 77° F (20° - 25°C).
Package Labeling:

Active Ingredients (Active ingredients)

Hydrocortisone 1%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, cetyl alcohol, dimethicone, EDTA, ethylparaben, glycerin, glyceryl monostearate, isohexadecane, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 80, propylene glycol, sodium citrate, stearic acid, tocopherol, water, zingiber officinale (ginger) root extract

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).


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