Duane Reade
FDA Label NDC 24488-034

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 24488-034). 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

Enter section text here

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 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

  • 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

  • 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
  • conditions 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 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 12 years of age: 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
      • 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 Ingredient

purified water/aqua/eau; glyceryl stearate and peg-100 stearate; c12-15 alkyl benzoate; isopropyl myristate; cetearyl alcohol and ceteareth-20; magnesium aluminum silicate; aloe barbadensis leaf juice; citric acid; polysorbate 80; sodium lauryl sulfate; propylene glycol,diazolidinyl urea, methlyparaben, propylparaben

Questions?

Call 1-866-923-4914

Package Label.Principal Display Panel

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Dr_hydrocort_crm_aloe1oz_label (Dr Hydrocort Crm Aloe1oz)

Dr_hydrocort_crm_aloe1oz_label (Dr Hydrocort Crm Aloe1oz)





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