Flex24 Pain
FDA Label NDC 73218-001

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 73218-001). 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, do not, stop use and ask a doctor if, caution, 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

Menthol, 10%

Camphor, 3%

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only

Do Not

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

Stop Use And Ask A Doctor If

conditions worsens or if symptoms persist for more than 7 days

Caution

  • Discontinue use if there is redness or excessive irritation on skin
  • Avoid contact with eyes
  • Arthritis: If pain persists more than 10 days or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 times daily
  • Children under 2 years old: consult a doctor
  • Tear and apply in a circle of 25 mm diameter to affected area and spread smoothly over the skin with fingers
  • Wash fingers that applied cream with water.  Do not rub eyes with fingers until washed with water

Inactive Ingredients

Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aqua (Deionized water), Arnica Montana flower extract, Ascorbic Acid (Vitamin C), Beta Glucan, Boswellia Extract, Ceramide NG, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Distearyldimonium Chloride, Gluconolactone, Glyceryl Stearate, Glycerin, Helianthus Annuus (sunflower) oil, Lactic acid, Magnesium Sulfate, Melaleuca Alternifolia (Tea tree) oil, Xanathan Gum, Methylsulfonylmethane (MSM), PPG 12/SMD1 copolymer, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, SD-Alcohol 40B, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol

Package Label.Principal Display Panel

FLEX24

RECOVER NATURALLY

PAIN CREAM

SAMPLE PACK

NET wt. 0.14 oz (3.8g)

Dist: FLEX24, INC.

4020 GALT OCEAN DRIVE, STE. 1607

FORT LAUDERDALE, FL 33308

CALL TOLL FREE 844.4.FLEX24

NDC 73218-001-01

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