Anti Itch Cream
FDA Label NDC 51141-0054

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neopharm Co., Ltd. for the product Anti Itch Cream (NDC 51141-0054). 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 ingredients (in each gram), purposes, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Gram)

Diphenhydramine HCl 2%

Zinc acetate 0.1%

Purposes

Topical analgesic

Skin protectant

Uses

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

Warnings

For external use only

Do Not Use

  • on chicken pox or measles
  • with any other product containing diphenhydramine, even one taken by mouth
  • on large areas of the body, including large areas of poison ivy, sunburn, or broken, blistered or oozing skin

Stop Use And Ask A Doctor If

  • condition worsens or does not improve within 7 days
  • symptoms persist 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

  • adults and children 12 years of age and over:  apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age:  ask a doctor
  • do not use more often than directed

Other Information

  • store at 59° to 77°F

Inactive Ingredients

Carbomer 940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Methylparaben, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Propylparaben, Purified water

Package Label

Anti-Itch Cream

Image Of A Carton Label (Antiitch.carton)

Image Of A Carton Label (Antiitch.carton)

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