Smart Pro
FDA Label NDC 76092-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by M J Winston International Ltd.. for the product Smart Pro (NDC 76092-101). 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 ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

  • DL-Camphor 1.20 %
  • L-Menthol 5.70 %
  • Methyl Salicylate 6.30 %

Purpose

Topical Analgesic

Uses

for temporary relief of minor pain associated with:

  • arthritis
  • simple backache
  • tendonitis
  • muscle strains
  • bruises

Warnings

    For external use only
  • If pregnant or breast feeding, consult a healthcare professional.
  • Allergy Alert: If you are allergic to any ingredients of this product, ask a doctor before use.

When Using This Product

  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes and mucous membranes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist more than 7 days or clear up and occur again within a few days
  • rash, itching, excessive skin irritation develops.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age and older
  • clean and dry affected
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily for 7 days
  • Children under 12 years of age consult a doctor

Other Information

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

Inactive Ingredients

Butylated Hydroxy Toluene, Dihydroxy Aluminum Amino Acetate, Disodium Edetate, Gelatin, Glycerin, Kaolin, Magenesium Aluminometasilicate, Methyl Paraben, Polysorbate 80, Polyvinyl Alcohol, Purified Water, Sodium Polyacrylate, Sorbitan Sesquioleate, Tartaric Acid, Titanium Dioxide

Questions Or Comments?

Distributed by

M J Winston International, Ltd.

San Dimas, California 91773

www.smartmed.us

Made in Korea

Package/Label Principal Display Panel

SMART PRO PATCH

Wellpatch Pain Relief Patch (Display)

Wellpatch Pain Relief Patch (Display)

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