Duane Reade
FDA Label NDC 24488-033

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Duane Reade for the product Duane Reade (NDC 24488-033). 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 ingredients..........................purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients..........................Purpose

Hydrocortisone 1%..........................Anti-Itch

Uses

Temporary relief of itching associated with minor skin irritations and rashes due to
  • eczema
  • insect bites
  • poison ivy, poison oak, or poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • external genital or 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

  • in the eyes
  • by putting this product into the rectum by using fingers or any other mechanical device or applicator

Ask A Doctor Before Use If You Have

  • a vaginal discharge
  • rectal bleeding
  • diaper rash

When Using This Product

consult a doctor before exceeding recommended dosage

Stop Use And Ask A Doctor If

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contract 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

    For external anal itching:
    • Adults: when practical, cleanse 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 application of this product.
      • Children under 12 years of age: consult a doctor

Other Information

  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Petrolatum

Package Label.Principal Display Panel

Placeholder text

Dr_hydrocortisone_ointment_max_strength_ Label (Dr Hydrocortisone Ointment Max Strength)

Dr_hydrocortisone_ointment_max_strength_ Label (Dr Hydrocortisone Ointment Max Strength)

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