Duane Reade
FDA Label NDC 24488-032

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 24488-032). 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, 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 Ingredient........................Purpose

Hydrocortison 1%........................Anti-itch

Uses

temporarily relief of itching associated with minor skin irritations and rashes due to

  • eczema
  • insect bites
  • poison ivy, poison oak, and poison sumac
  • soaps
  • detergents
  • cosmetics
  • 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 mechanical device or applicator.

Ask A Doctor Before Use If You Have

  • vaginal discharge
  • rectal bleeding
  • diaper rash

When Using This Product

consult a doctor before exceeding the 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 another hydrocortisone product unless you have consulted a doctor.

Keep Out Of Reach Of Children.

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

Directions

Adult and children 2 years of age and older:

  • apply to the affected area no more than 3-4 times daily
    • children under 2 years: 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

purified water/aqua/eau; glyceryl stearate and peg-100 stearate; c12-15 alkyl benzoate; isopropyl myristate; cetearyl alcohol and ceteareth-20; magnesium aluminium silicate; aloe barbadensis leaf juice; cholecalciferol (vitamin d3); citric acid; polysorbate 80; retinyl (vitamin a) palmitate; tocopheryl (vitamin e) acetate; propylene glycol; diazolidinyl urea; methylparaben; propylparaben

Questions?

Call 1-866-375-6925

Package Label.Principal Display Panel

place holder text

Dr_hydrocort_12moist_label (Dr Hydrocort 12moist Label)

Dr_hydrocort_12moist_label (Dr Hydrocort 12moist Label)

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