Family Care Thera Flex Pain
FDA Label NDC 65923-100

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 Thera Flex Pain (NDC 65923-100). 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 - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, 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 (in each patch)                                                                                           Purpose

Capsaicin 0.0056%...............................................................................................................Topical analgesic

DL-Camphor 1.48%...............................................................................................................Topical analgesic

L-Menthol 3.95%...................................................................................................................Topical analgesic

Methyl salicylate 3.95%.........................................................................................................Topical analgesic

Peppermint oil 1.95%.............................................................................................................Skin protectant

Zinc oxide 18.77%.................................................................................................................Skin protectant

Otc - Purpose

Uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

  • strains
  • sprains
  • simple backache
  • arthritis
  • bruises

Warnings

Warnings   For external use only

Otc - When Using

When using this product

  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Otc - Stop Use

Stop use and ask a doctor if

  • conditions worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Do not use on infants.  If swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

Directions

adults and children over 12 years:

  • carefully remove backing from patch
  • apply sticky side of patch to affected area
  • repeat as necessary, but no more than 4 times daily
    • children 12 years or younger:

    • ask a doctor

Storage And Handling

Other information

  • some individuals may not experience pain relief until several hours after applying the patch
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
  • store at 20o-25oC (68o-77oF)

Inactive Ingredient

Inactive ingredients

butylated hydroxytoluene, calcium carbonate, glyceryl rosinate, natural rubber, polybutene, polyisobutylene, terpene resin

Dosage & Administration

Distributed by:

UNITED EXCHANGE CORP.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Fctheraflexpatch)

Image Of Carton Label (Fctheraflexpatch)

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