Hydrocortisone Lotion
FDA Label NDC 0394-0859

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mericon Industries for the product Hydrocortisone (NDC 0394-0859). 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 other, active ingredient, purpose, uses, warnings, stop using this product and ask a doctor, do not use this product and ask a doctor, for external anal itching users, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For External Anal Itching Users

  • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, and 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

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

For the temporary relief associated with minor skin irritations, inflammation and rashes due to:

  • eczema
  • seborrheic dermatitis
  • psoriasis
  • insect bites
  • poison ivy, oak, sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • 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
  • avoid contact with the eyes

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

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

For External Anal Itching Users

  • 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

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children

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

Other Information

  • store at 55 to 76F

Inactive Ingredients

stearic acid, propylene glycol, lanolin alcohol in mineral oil, isopropyl in myristate, cetyl alcohol, mono- and di-glycerides, polysorbate 80, sorbitan monooleate, a scent and purified water preserved with methylparaben and propylparaben.

Principal Display Panel - 114 G Bottle Label

0394-0859-32

Mericon Industries, Inc.

Hydrocortisone 1%
Lotion

Anti-Itch
Poison Ivy
Poison Oak
Poison Sumac
Hives • Rashes

Net Wt. 4 oz. (114g)

Principal Display Panel (114 g Bottle Label)

Principal Display Panel (114 g Bottle Label)

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