1% Hydrocortisone Anti-itch Cream
FDA Label NDC 73492-291

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alaina Healthcare Private Limited for the product 1% Hydrocortisone Anti-itch (NDC 73492-291). 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 uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

  • for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • seborrheic dermatitis
    • psoriasis
    • insect bites
    • poison ivy, poison oak, and poison sumac
    • cosmetics
    • jewelry
    • detergents
    • soaps
    • temporarily relieves external anal and genital 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. Ask a doctor.
  • for external genital itching if you have a vaginal discharge. Ask a doctor.

When Using This Product

  • do not get into the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

  • condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.
  • rectal bleeding occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 2 years and over:apply to affected area not more than 3 to 4 times daily
  • children under 2 years:ask a doctor
  • for external anal and genital itching in adults:
  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroghly.
  • 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
  • for external anal and genital itching in children under 12 years:ask a doctor

Other Information

  • store at 20°c to 25°c (68°F to 77°F)

Lnactive Ingredients

Aloe Barbadensis Leaf Extract, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Ethylhexylglycerin, Glycerin, Glyceryl Monostearate, Light Liquid Paraffin, Petrolatum, Phenoxyethanol, Sodium Lauryl Sulfate, Water

Principal Display Panel

​​​​​​​1% Hydrocortisone Anti-Itch Cream ​​​​​​​with Aloe Vera
Maximum Strength Cream
Inflamation & Redness
​​​​​​​Skin Irritation & Rashes
Insects Bites, Poison Ivy
Eczema & Psoriasis

Net wt. 1 oz (28 g)

"image Description" (Hydrocortisone Cream 28g Tube Label)

"image Description" (Hydrocortisone Cream 28g Tube Label)

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