Hydrocortisone Lotion
FDA Label NDC 71399-0120

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc for the product Hydrocortisone (NDC 71399-0120). 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 active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, 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

Active Ingredient

Hydrocortisone 1% (Micronized)

Purpose

Antipruritic (Anti-itch)

Use

For the temporary relief of minor skin irritations, inflammations, itching and rashes caused by:

  • insect bites
  • eczema
  • psoriasis
  • soaps
  • detergents
  • cosmetics,
  • jewelry,
  • poison oak,
  • poison sumac
  • Other uses of this product should be undertaken only under the advice and supervision of a doctor.

Warnings

For external use only.

When Using This Product

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor If

  • Condition worsens
  • If symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
  • Do no use for diaper rash. Consult a doctor.

Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

  • Shake will before using.
  • For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.
  • For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a doctor.

Other Information

• Store away from excessive heat or cold. Shake well before using.

Inactive Ingredients

Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Lauryl Sulfate, Stearyl Alcohol, Aloevera, Xanthan Gum

Questions?

Please Call 1(877) 225-6999

Other

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ 07004

Rev. 03/19

Manufactured in U.S.A

Package Label.Principal Display Panel

Carton (Hydroc Lotion)

Carton (Hydroc Lotion)

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