Rapidol Cream
FDA Label NDC 55758-420

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Rapidol (NDC 55758-420). 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 otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding,, 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

Otc - Purpose

Active ingredientPurpose

Hydrocortisone 1%...............................................

Anti-itch

Uses

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
  • detergent
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • and for external feminine, genital, and anal itching
  • for other uses of this product should only be under the advice and supervision of a doctor

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

Do Not Use

  • for treatment of diaper rash. Consult a doctor
  • if you have a vaginal discharge. Consult a doctor.
  • with any other hydrocortisone product unless you have consulted a doctor

When Using This Product

  • for external anal itching: Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days and occur again within a few days

Keep Out Of Reach Of Children.

If accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Directions

For itchy skin, irritations, inflammation, rashes and external feminine and genital itching:

  • adults and children 2 years of age and older: apply to the 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

  • store in a cool dry place
  • do not use if foil seal under cap is torn, broken, or missing

Inactive Ingredients

aloe vera leaf, cetostearyl alcohol, dimethicone, dimethyl sulfoxide, edetic acid, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, mineral oil, propylparaben, stearic acid, tocopherol acetate (vitamin E), trolamine, water

Questions?

+1-866-359-3478 (M-F) 9AM to 5 PM EST or www.pharmadel.com

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