Hydrocortisone
FDA Label NDC 62985-5125

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by First Aid Only, Inc for the product Hydrocortisone (NDC 62985-5125). 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 ingredients, purpose, uses, warnings, do not use, stop use, ask a doctor, 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

Other

Drug Facts

Active Ingredients

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For temporary relief of itching associated with minor skin irritations, inflammation or rashes. Other uses of product should be only under the advice and supervision of a doctor.

Warnings

For external use only

Do Not Use

  • in eyes
  • for treatment of diaper rash

Stop Use, Ask A Doctor

  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with use of other hydrocortisone products

Keep Out Of Reach Of Children.

If ingested, contact a Poison Control Center right away

Directions

  • apply to affected area not more than 3 to 4 times dally
  • children under 2: ask a doctor

Inactive Ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Package Label.Principal Display Panel

Principal Display Panel - Packet Label

Anti-Itch
Cream

0.9g (1/32 OZ)

FIRST AID ONLY.

www.FirstAidOnly.com

Fairfield, CT 06824

1.800.835.2263

© 2015 Acme United Corporation.

810002-revA

Principal Display Panel (Packet Label)

Principal Display Panel (Packet Label)

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