Flex24 Pain
FDA Label NDC 54641-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Larasan Pharmaceutical Corporation for the product Flex24 Pain (NDC 54641-008). 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, otc - stop use, 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, cramps, bruises, and sprains.

Warnings

For external use only

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.

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 immediately.

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 2 years of age or older: Apply to affected area as and when required.
• Remove the cap and apply in a circle of 25 mm diameter (size of a quarter) 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.
• Children under 2 years old: consult a doctor

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 4013, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol

Other Information

Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure

Questions/Comments?

www.FLEX24.com/paincream

Other

Larasan Pharmaceutical Corp.

1287 E. Newport Center Drive, Suite 206

Deerfield Beach, FL 33442

Made in USA

54641-008-01

Package Label.Principal Display Panel

Pain Cream

Pain Relief

  • Long Lasting
  • Invisible
  • No smell

    • 3.4 oz (96 g)

    • Fast and Long-Lasting Pain Relief
    • Smooth, Non-Sticky, Pleasant Smell
    • Invsible Relief for Hours

      • Flex24(r)

      Recover Naturally

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