Flex24 Pain
FDA Label NDC 73218-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Flex24 Inc for the product Flex24 Pain (NDC 73218-002). 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 active ingredients, purpose, uses, warnings, otc - do not use, otc - stop use, warnings and precautions, 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

Active Ingredients

Camphor, 3%

Menthol, 2.52%

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains, cramps, bruises, and sprains.

Warnings

For external use only

Otc - Do Not Use

Do not

  • Apply to open wounds, or damaged, broken, or irritated skin

Otc - Stop Use

Stop use and ask a doctor if condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Warnings And Precautions

Caution

  • Discontinue use if excessive irritation of the skin develops
  • Avoid contact with the eyes and mucous membranes
  • Arthritis: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immedately

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.

Directions

Adults and children over the age of 12:

  • Remove plastic backing from patch and discard
  • Apply one patch to affected area
  • Repeat if necessary, but no more than 3 per day
  • Patch should be comfortable but not tight
  • Sensitive skin – Remove patch under water

    • Children under 12: consult a doctor before use

Inactive Ingredients

Angelica Dahurica Root, Atractylodes Lancea Root, Borneol, Chinese Angelica, Chondroitin Sulfate, Ginger, Kaempferia Galanga Root, Kusnezoff Monkshood Root (raw), Lemon, Ligusticum Sinense/Subsp. Chuanxiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, Rosin, Silicone, Star Anise, Wintergreen Oil, Zinc Oxide

Other

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Dist: FLEX24, INC.

        4020 Galt Ocean Mile, Ste. 1607

        Ft. Lauderdale, FL 33308

       Tel: 844.4.FLEX24

Formulated in the USA

Package Label.Principal Display Panel

FLEX24.COM

FLEX24®

RECOVER NATURALLY

TOPICAL ANALGESIC PAIN PATCH

24 Hour Relief

7 Large Patches

Patch size 8 cm x 13 cm

All Natural

Long Lasting

Reduces Pain

Strong Natural Pain Relief

20190828_73218_patch (20190828 73218 Patch)

20190828_73218_patch (20190828 73218 Patch)

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