Itch Relief
FDA Label NDC 68421-8300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas First Aid & Safety for the product Itch Relief (NDC 68421-8300). 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 other, active ingredients, purpose, uses:, warnings, do not use, ask a doctor before use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Diphenhydramine hydrochloride 2%

Purpose

External Analgesic

Uses:

For the temporary relief of pain and itching associated with minor skin irritations and rashes due to insect bites, 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 hydrochloride, even one taken by mouth

Ask A Doctor Before Use

  • on chicken pox
  • on measles

When Using This Product

  • avoid contact with the eyes

Stop Use And Ask Doctor If

  • condition worsens
  • symptoms persist 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 children If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • do not use more than directed
  • adults & children12 and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: consult a doctor

Inactive Ingredients

germaben II, edetate disodium, glycerin, tomadol 25-9, purified water, triethanolamine

Principal Display Panel - Bottle Label

Extra Strength
Itch Relief

Quick Itch & Pain Relief
Diphenhydramine HCl 2%

Convenient pump
spray allows no-touch
application. Use as a
first aid treatment for
insect bites and
rashes from poison
ivy, oak & sumac.

2 fl. oz. (59.1 mL)

Xpect®

First aid

Principal Display Panel (Bottle Label)

Principal Display Panel (Bottle Label)

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