Itch Relief Gel
FDA Label NDC 0363-0353

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Itch Relief Gel (NDC 0363-0353). 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 ingredient, purpose, use, warnings, do not use:, ask a doctor before use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Diphenhydramine HCL 2%

Purpose

Topical Analgesic

Use

Temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, rashes due to 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, 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

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.

Apply to affected area not more thatn 3 to 4 times daily

Other Information

Store at room temperature

Inactive Ingredients

camphor, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, purified water, SD alcohol 40-B, sodium citrate

Questions?

1-800-925-4733

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