Topcare Hydrocortisone Cream
FDA Label NDC 36800-939

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Hydrocortisone (NDC 36800-939). 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 active ingredient, purpose, uses, directions, 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

Active Ingredient

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 only be under the advice and supervision of a doctor

Directions

Click here to enter 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 a 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

Warnings

For external use only

Do Not Use

  • for the treatment of diaper rash. Ask a doctor.
  • in the genital area if you have a vaginal discharge. Ask a doctor.

When Using This Product

  • avoid contact with the 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 persist 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.

Other Information

store at 20°-25°C (68°-77°F)

Inactive Ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, diazolidinyl urea, dimethicone, distearyldimonium chloride, edetate disodium, glycerin, glyceryl monostearate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, jojoba esters, magnesium ascorbyl phosphate, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, potassium hydroxide, PPG-12/SMDI copolymer, propylparaben, purified water, retinyl palmitate, stearamidopropyl PG-dimonium chloride phosphate, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate

Questions Or Comments?

1-888-423-0139

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COMPARE TO CORTIZONE ·10®

INTENSIVE HEALING FORMULA

ACTIVE INGREDIENT

Itch & Rash Relief Cream

Intensive Healing Formula†

Relieves Itch

†Contains Healing Moisturizers Enriched with Vitamins A, C & E

With Antioxidants & Chamomile

MAXIMUM STRENGTH

OUR PHARMACISTS RECOMMEND

Hydrocortisone 1% Cream

ANTI-ITCH CREAM

Intensive Healing Formula†

NET WT 1 OZ (28 g)

* Please review the disclaimer below.