Anti Itch Topical Analgesic
FDA Label NDC 63868-708

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Associations Inc for the product Anti Itch Topical Analgesic (NDC 63868-708). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients Purpose

Diphenhydramine HCI 2%........................................................Topical analgesic

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

Otc - Purpose

Uses

  • temporarily relieves pain and itching associated with:
  • insect bites
  • minor burns
  • minor skin irritations
  • sunburn
  • minor cuts
  • scrapes
  • rashes due to poison ivy, oak, and sumac
  • dries the oozing and weeping of poison:
  • ivy
  • oak
  • sumac

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use

  • on chicken pox
  • on measles

Otc - When Using

When using this product avoid contact with the eyes

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 children

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

Indications & Usage

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
  • children under 2 years of age: ask a doctor

Storage And Handling

Other information

  • store at room temperature 20-25°C (68-77°F)
  • protect from excessive heat (40°C/104°F), humidity, and light

Inactive Ingredient

inactive ingredients

cetostearyl alcohol, glyceryl stearate/peg-100 stearate, methylparaben, propylene glycol, propylparaben, purified water

Dosage & Administration

DISTRIBUTED BY:

C.D.M.A. INC.

43157 W. 9 Mile Road

Novi, MI 48375

www.qualitychoice.com

Made in China

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