Hydrocortisone 1% Anti-itchcream
FDA Label NDC 0924-5634

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product Hydrocortisone 1% Anti-itchcream (NDC 0924-5634). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

(Anti-itch)

Uses

  • temporarily relieves itching associated with minor skin irritations and rashes
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Avoid Contact with the eyes

Do Not Use

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. Consult a doctor.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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: consult a doctor.

Other Information

store at room temperature 68-77°F (20-25°C)

Inactive Ingredients

cetostearyl alcohol, glyceryl monostearate SE, kathon CG, propylene glycol, purified water, stearic acid, trolamine, white petrolatum

Questions?

Call 1-800.835.2263

Package Labeling:

Carton Label (807716 001 Reva Fda)

Carton Label (807716 001 Reva Fda)

* Please review the disclaimer below.