Hydrocortisone Cream
FDA Label NDC 47682-211

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Hydrocortisone (NDC 47682-211). 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 (in each gram), purpose, uses, warnings, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Gram)

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For the temporary relief of itching associated with minor skin irritations and rashes due to

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • cosmetics
  • jewelry
  • soaps
  • detergents
  • seborrheic dermatitis
  • psoriasis

    • 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
  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor
  • do not use for the treatment of diaper rash

Keep Out Of Reach Of Children.

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

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

Other Information

  • store at room temperature 59°-86°F (15°-30°C)
  • do not freeze
  • do not use any opened or torn packets

Inactive Ingredient

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

Questions Or Comments?

1-800-634-7680

Principal Display Panel – 144 Unit Box Label

MEDI-FIRST

1% Hydrocortisone
Cream

Temporary relief of itching associated with
minor skin irritation, inflammation and rashes

Para el alivio temporal de la comezón asociada con leves
irritaciones, inflamaciones y sarpullidos de la piel

0.9g (1/32oz) Packets
144 per box

Principal Display Panel – Pouch

1% HYDROCORTISONE CREAM

ANTI-ITCH CREAM

1/32oz. (0.9g)

Manufactured for Medique Products, Fort Myers, FL 33967 USA

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