Walgreens Original Strength Anti Itch Cream
FDA Label NDC 0363-4115

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Walgreens Original Strength Anti Itch (NDC 0363-4115). 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 facts, otc - purpose, warnings, otc - ask doctor, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Igredients                                                                      Purpose

Diphenhydramine hydrochloride 1%...................................Topical analgesic

Zinc acetate 0.1%..............................................................Skin protectant

Otc - Purpose

Uses

Temporarily relieves pain and itching associated with

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • minor cuts
  • scrapes
  • rashes due to poision ivy, poision oak, and poision sumac
  • dries the ozzing and weeping of poision ivy, poision oak, and poision 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 

Otc - Ask Doctor

Ask a doctor before use

  • on chicken pox
  • on measles

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of chilren, if swallowed, get medical help or contact a Poision Control Center.

Indications & Usage

Directions

  • do not use more than directed
  • adults and children 2 years of age and older
  • apply to affected area no more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Storage And Handling

Other Information

  • store between 20°C to 25°C (68°F to 77°F)

Inactive Ingredient

Inactive Ingredients

cetanol, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alchol

Dosage & Administration

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

* Please review the disclaimer below.