Maximum Strength Hydrocortisone Ointment
FDA Label NDC 24286-1560

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dlc Laboratories, Inc for the product Maximum Strength Hydrocortisone (NDC 24286-1560). 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, warnings, do not use, when using this product, stop use and ask a doctor, keep out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Antipuritic (Anti-Itch)

Uses

  • for the temporary relief of itching associated with minor itching associated with minor skin irritatitions, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
  • for external genital, feminine and anal itching
  • 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. Consult a doctor
  • for external feminine itching if you have a vaginal discharge. Consult 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 this product into rectum by using fingers or any medical device or applicator

Stop Use And Ask A Doctor

if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor
  • rectal bleeding occurs

Keep Out Of The Reach Of Children.

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

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

Other Information

store at room temperature 15-30C (59-86F)

Inactive Ingredients

mineral oil, petrolatum

Product Labeling

For fast relief of itching due to:

  • Eczema and Psoriasis
  • Insect bites
  • Soaps and detergents
  • Poison Ivy and Poison Sumac
    • Maximum Strength  Hydrocortisone 1%
    For relief of itching, rashes, and skin irritations




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