Hydrocortisone Cream
FDA Label NDC 73598-1014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jhk Inc Dba American Safety & First Aid for the product Hydrocortisone (NDC 73598-1014). 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, use, warnings, do not use, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Active Ingredient

Hydrocortisone acetate 1%

Purpose

Anti-Itch Cream

Use

Temporarily relieves itching associated with minor skin irritations and rashes due to:

  • Eczema
  • Insect Bites
  • Poison Ivy, Oak or Sumac
  • Soaps, Detergents or Cosmetics
  • Jewelry

Warnings

For external use only

Do Not Use

  • With any other hydrocortisone product unless you have consulted a doctor
  • For the treatment of diaper rash, consult a doctor

Stop Use And Ask A Doctor If

  • Condition worsens
  • Symptoms persist for more than seven days
  • Symptoms clear up and occur again within a few days

Keep Out Of Reach Of Children

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

Directions

  • Adults and children two years and over: apply to affected area not more than three to four times daily
  • Children under two years: Do not use

Other Information

  • Do not use if packet is torn, cut or opened
  • Store at room temperature (do not freeze)
  • See packet for Lot Number and expiration date

Inactive Ingredient

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin/Phenoxyethanol Glycerin, Glycerol fatty acid ester Mineral Oil, Petrolatum, Water

Questions?

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Principal Display Panel - 25 Packet Carton

Product #1014

Hydrocortisone Cream
USP 1%

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

25 - Unit Dose Packets

Principal Display Panel (25 Packet Carton)

Principal Display Panel (25 Packet Carton)

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