Itchzap Cream
FDA Label NDC 57237-352

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Itchzap (NDC 57237-352). 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 drug factsactive ingredients, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredients

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

  • temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy, poison oak and poison sumac
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

    • Ask a doctor before use

    • on chicken pox
    • on measles

      • When using this product

      • avoid contact with eyes

        • Stop use and ask a doctor if

        • condition worsens or does not improve within 7 days
        • symptoms persists for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

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

Directions

  • do not use more than directed
  • 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

Other Information

  • store between 15°C - 25°C (59°- 77°F)
  • Lot No. & Exp Date: See box or crimp of tube

Inactive Ingredients

Benzyl alcohol, cetyl alcohol, glyceryl monostearate SE, glyceryl stearate/PEG 100 stearate, propylene glycol, water

Questions And Comments?

Call 1-844-474-7464

ItchZapTM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/1362

Principal Display Panel

NDC 57237-352-28

ItchZapTM 

Diphenhydramine Hydrochloride 2% & Zinc Acetate 0.1%

Anti-Itch Cream

Extra Strength

Topical Analgesic/Skin Protectant

Diphenhydramine-zinc-acetate (Diphenhydramine Zinc Acetate)

Diphenhydramine-zinc-acetate (Diphenhydramine Zinc Acetate)

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