Anti-itch Cream
FDA Label NDC 53329-091

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Anti-itch (NDC 53329-091). 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 (in each gram), purpose, uses, warnings, do not use, consult a doctor, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Gram)

Hydrocortisone USP 10mg

Purpose

Antipuritic (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, scrapes
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

for external use

Do Not Use

  • for the treatment of diaper rash
  • with any other Hydrocortisone product unless you have consulted a doctor

Consult A Doctor

  • before use if you have a vaginal discharge (for external feminine itching)
  • for external itching, do not exceed the recommended daily dosage or if bleeding occurs
  • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

When Using This Product

  • avoid contact with eyes
  • do not put this product into rectum by using fingers or any mechanical device or applicator

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 not more than 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

  • Protect from freezing. Avoid excessive heat.
  • Do not use if packet is torn, cut or opened.

Inactive Ingredients

Citric acid, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide

Package/Label Principal Display Panel

Curad Hydrocortisone Cream

Curad Hydrocortisone Cream

CURAD

WE HELP HEAL

Hospital Quality

Hydrocortisone Cream 1%

Latex Free Product

Net Wt. 1 oz (28.4g)

Hydrocortisone Cream 1%

1% Hydrocortisone Anti-Itch

NET WT. 1 oz (28.4 g)

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