Maximum Strength Hydrocortisone Anti-itch Cream
FDA Label NDC 11673-890

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Maximum Strength Hydrocortisone Anti-itch (NDC 11673-890). 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, uses, warnings for external use only, directions, other information, inactive ingredients:, questions & comments ? 1-800-910-6874, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For 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
  • external feminine, genital and anal itching.
  • Other uses of this product should be only under the advice and supervision of a doctor.

Warnings For External Use Only

Do not use 

  • for the treatment of diaper rash, consult a doctor.
  • for external genital itching if you have a vaginal discharge, consult a doctor.

    • When using this product 

    • avoid contact with eyes
    • do not use more than directed unless told ot do so by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator.

      • Stop use and ask a doctor if 

      • condition worsens
      • 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 directed by a doctor.
      • rectal bleeding occurs 

Directions

For itching of skin irritation, inflammation, and rashes:

  • ■ 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: ask a doctor

    •  For external anal and genital itching, adults:

    • ■ when practical, clean the affected area with mild soap and warm water and rinse thoroughly
    • ■ gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • ■ apply to affected area not more than 3 to 4 times daily
    • ■ children under 12 years of age: ask a doctor

Other Information

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

Inactive Ingredients:

 Aloe Barbadensis Leaf Juice, Aluminum Sulfate, Beeswax, Calcium Acetate, Cetearyl Alcohol, Dextrin, Glycerin, Maltodextrin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Purified Water

Questions & Comments ? 1-800-910-6874

Principal Display Panel

Target Up&Up       NDC 11673-890-56

Maxminium Strenght Hydrocortisone Cream 

Hydrocortisone 1%

Anti-itch 

NET WT 2OZ (56g)

TOTAL NET WT 4OZ (112g)

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