Effective Itch Relief
FDA Label NDC 36800-739

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco for the product Effective Itch Relief (NDC 36800-739). 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, purpose, 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

Diphenhydramine HCl 2.0%

Zinc Acetate 0.10%

Purpose

Topical analgesic

Skin protectant

Uses

Temporarily relieves pain and itching associated with:

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

Warnings

For external use only.

Flammable - Do not use while smoking or near heat or flame ​​​​

Do Not Use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
  • on chicken pox

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days

Keep Out Of Reach Of Children.

If swallowed, get help or contact a Poison Control Center right away.

Directions

  • shake well
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
  • to apply to face, spray into palm of hand and gently apply

Inactive Ingredients

Alcohol Denat.
Glycerin
PVP
Tromethamine
Water

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