Thera Plus Anti-itch With Aloe Hydrocortisone Cream
FDA Label NDC 80684-038

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fourstar Group Usa, Inc. for the product Thera Plus Anti-itch With Aloe Hydrocortisone (NDC 80684-038). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Hydrocortisone 1%

Purpose

Anti-itch

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.

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.

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 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.

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

Other Information

  • store at room temperature 68°-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

Questions?

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