Western Family Itch Relief
FDA Label NDC 55312-053

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Western Family Food, Inc. for the product Western Family Itch Relief (NDC 55312-053). 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 - keep out of reach of children, 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 Hydrochloride 2%..............................................................Topical analgesic

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

Otc - Purpose

Uses temporarily relieves pain and itching associated with:

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

Warnings

Warnings For external use only.

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use

  • on chicken pox
  • on measles

Otc - When Using

When using this product

  • avoid contact with 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.

Indications & Usage

Directions

  • do not use more than directed
  • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Storage And Handling

Other information

  • store between 20°C and 25°C (68°F and 77°F)

Inactive Ingredient

Inactive ingredients cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, and purified water

Dosage & Administration

Proudly Distributed by:

Western Family Foods, Inc.

P.O. Box 4057

Portland, OR 97208 U.S.A.

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Wfitch)

Image Of Carton Label (Wfitch)

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