Itch Relief Liquid
FDA Label NDC 61010-8300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Itch Relief (NDC 61010-8300). 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 products using 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:

  • 12 and over: apply to affected area not more than 3 to 4 times daily
  • under 12: consult a doctor

Inactive Ingredients:

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

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NDC 61010-8300-1

Safetec

Diphenhydramine

Itch Relief Spray

Relief from pain and

itching due to insect

bites and rashes from

poison ivy, poison oak

and poison sumac.

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077

www.safetec.com

2 fl. oz. (59.1ml) Reorder no. 57001

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Principal Display Panel (Saf0q 0000 01)

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