Family Care Pain Relief
FDA Label NDC 65923-385

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Pain Relief (NDC 65923-385). 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

DL-Camphor 1.2%....................................................Topical Analgesic

L-Menthol 5.7%........................................................Topical Analgesic

Methylsalicylate 6.3%................................................Topical Analgesic

Otc - Purpose

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backaches
  • strains
  • bruises
  • sprains

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

  • on wounds or damaged skin
  • if you are allergic to aspirin or salicylates
  • with a heating pad
  • with, or at the same time as, other external analgesic products

Otc - Ask Doctor

Ask a doctor before use, if you are allergic to any ingredients in this product

Otc - When Using

When using this product

  • do not use otherwise than directed
  • avoid contact with the eyes, mucous membranes or rashes

Otc - Stop Use

Stop use and ask a doctore if

  • rash, itching or excessive skin irritation develops
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms 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 Poision Control Center right away

Indications & Usage

Directions

Aduts and children 12 years of age and over:

  • clean and dry affected area
  • remove patch from film
  • apply to affected area no more than 3 to 4 times daily for 7 days
  • remove patch from skin after at most 8 hours of application

    • Children under 12 years of age:

    • consult a doctor

Storage And Handling

Other Information

  • avoid storing product in direct sunlight
  • protect from excessive moisture

Inactive Ingredient

Inactive Ingredients

BHT, calcium carbonate, C4-6 oletin / styrene copolymer, glycerol abietate, isopropyl myristate, polybutene, polyisobutene, propylene carbonate, rubber latex, sorbitian stearate, ys resin, zinc oxide

Dosage & Administration

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703

Package Label.Principal Display Panel

Image Description (Fcpainpatch)

Image Description (Fcpainpatch)

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