Kera Hc Cream
FDA Label NDC 44577-623

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Clinical Therapeutic Solutions for the product Kera Hc (NDC 44577-623). 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 kera hc cream hydrocortisone 1%, active ingredient, purpose, uses:, warnings, when using this product:, stop use and ask a doctor if:, 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

Kera Hc Cream Hydrocortisone 1%


Active Ingredient

Hydrocortisone-USP 1.00%

Purpose

Anti-Itch

Uses:

Temporarily relieves itching associated with minor skin irritations, inflammations and rashes due to:

  • Excessively Dry Skin, Eczema, Insect Bites, Poison Ivy, Oak or Sumac, Soaps, Detergents, Cosmetics, Jewelery, Seborrheic Dermatitis, Psoriasis
  • Other uses of this product should only be under the advice and supervisor of a doctor

Warnings

  • For external use only

When Using This Product:

  • Avoid contact with eyes
  • Do not use more than directed unless told to do so by a doctor

Stop Use And Ask A Doctor If:

  • Condition worsens or symptoms persist for more than 7 days, or if symptoms clear up, and then return

Keep Out Of Reach Of Children.

If swallowed, contact physician or poison control center immediately.


Store At Room Temperature (20-25 Degrees C) (68-77 Degrees F)


Directions:

For itching of skin irritation, inflammation and rashes:

  • Apply to affected area not more than 3 to  4 times daily.
  • Not for use by children under 2 years of age

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), C12-15 Alkyl Benzoate, c13-14 Isoparaffin, Ethylhexylglycerin, Glycerin, Heilianthus Annuus (Sunflower) Seed Oil, Laureth-7, Phenoxyethanol, Polacrylamide, Polysorbate-20, Tocopheryl Acetate (Vitamin E), Urea-USP.

Distributed By:

Clinical Therapeutic Solutions, PO Box 1257, Wall, NJ 07719  www.CTSRX.com

Kera Hc Cream Hydrocortisone 1% 2Oz/56G (44577-623-02)

Kerahc (Kerahc)

Kerahc (Kerahc)

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