Hydrocortisone Cream
FDA Label NDC 47682-397

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Hydrocortisone (NDC 47682-397). 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 other, active ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, ask a doctor before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Hydrocortisone 1.0%

Purpose

Antipruritic (Anti itch)

Uses

  • for external genital, feminine and anal itching
  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites,
    poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, scrapes
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

  • for the treatment of diaper rash
  • with any other Hydrocortisone product unless you have consulted a doctor

Ask A Doctor Before Use

  • if you have a vaginal discharge (for feminine itching)
  • for external itching, do not exceed the recommended daily dosage or if condition worsens or if symptoms persist for more than
    7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

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

Directions

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, consult a doctor

  • adults for external anal itching when practical, clean, clean the affected area with mild soap and warm water and rinse
    thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • external itching for children under 12 years of age, consult a doctor

When Using This Product

  • avoid contact with eyes
  • do not put this product into rectum by using fingers, mechanical device or applicator

Other Information

  • store at room temperature 15°-30°C (59°-86°F)
  • tamper Evident. Do not use if packet is torn, cut or opened
  • avoid excessive heat and humidity

Inactive Ingredient

emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Questions Or Comments?

1-800-869-6970

Principal Display Panel – 25 Unit Box

Maximum Strength

Hydrocortisone
cream 1%

0.9 Gram 25 Single Dose Packets
Distributed by Green Guard®, St. Louis, Missouri 63045

* Please review the disclaimer below.