Western Family Pain Relieving
FDA Label NDC 55312-054

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 Pain Relieving (NDC 55312-054). 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

Enter section text here

Otc - Purpose

Uses temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

Warnings for external use only.

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor

Ask a doctor before use if you have redness over the affected area.

Otc - When Using

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental ingestion.

  • If swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

Directions

  • use only as directed
  • adults and children 12 years of age and older: apply area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Storage And Handling

Other information

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

Inactive Ingredient

Inactive ingredients DEA-cetyl phosphate, glycerin, isopropyl myristate, methylparaben, polysorbate 60, propylparaben, purified lanolin, purified water, sorbitan stearate, stearyl alcohol, white petrolatum

Dosage & Administration

Distributed By:

Western Family Foods, Inc.

P.O. Box 4057

Portland, OR 97208 U.S.A.

Made in Korea

Package Label.Principal Display Panel

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