Hydrocortisone Cream
FDA Label NDC 61010-5800

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Hydrocortisone (NDC 61010-5800). 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, uses:, warnings:, otc - 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

Other

Drug Facts

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses:

  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings:

  • For external use only

Otc - Do Not Use

  • Do not use for the treatment of diaper rash
  • in eyes
  • for feminine itching
  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with any other Hydrocortisone product unless you have consulted a doctor

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 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 12 years of age: for external anal itching, consult a doctor

Other Information:

  • store at room temperature (do not freeze)
  • do not use any opened or torn packets

Inactive Ingredients:

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

Questions Or Comments? 1-800-456-7077

Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 . 800-456-7077
www.safetec.com

Principal Display Panel

PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label

Safetec

1% Hydrocortisone Cream™

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Principal Display Panel – Box Label

NDC 61010-5800-2

Safetec

First Aid

1% Hydrocortisone Cream

For Temporary Relief of

Itching Associated with

Minor Skin Irritations,

Inflammation, or Rashes

Reorder no. 53110

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

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