Family Care Hydrocortisone
FDA Label NDC 65923-472

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Hydrocortisone (NDC 65923-472). 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 - active ingredient, otc - purpose, warnings, otc - stop use, otc - do not use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                                       Purpose

Hydrocortisone 1%....................................................................Anti-itch

Otc - Purpose

Uses for the temporary relief of itching associated with minor skin irriations, inflammation and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • external genital, feminine and anal itching.
    • Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor

Warnings

Warnings

  • for external use only
  • avoid contact with eyes

Otc - Stop Use

Stop using this product 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
  • before you begin using any other hydrocortisone product

Otc - Do Not Use

Do not use this product and ask a doctor

  • if you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

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

Before using any medication, read all label directions.  Keep this carton.  It contains important information.

Indications & Usage

Directions

  • for 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

Storage And Handling

Other information

  • store at room temperature
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

glycerin, propylene glycol, sodium chloride, white petrolatum, cetyl alcohol, dimethicone, isopropyl palmitate, distearyldimonium chloride, methylparaben, propylparaben, purified water

Dosage & Administration

Distributed By:

UNITED EXCHANGE CORP.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Familycarehydrocortisone)

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