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SmartRx Natural Pain Relief Sleeve KNEE

Dosage form: liquid
Ingredients: METHYL SALICYLATE 10g in 100g
Labeler: Niche Brands, Inc.
NDC Code: 60589-004

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SmartRx Natural Pain Relief Sleeve KNEE

SmartRx Natural Pain Relief Sleeve KNEE


Active ingredient

Methyl Salicylate 10%

Purpose

External Analgesic (Counterirritant)

Use

for the temporary relief of minor aches and pains of muscles and joints associated with • arthritis • strains • bruises • sprains.

Warnings

For external use only. Avoid contact with the eyes.

When using this product
  • Do not use otherwise than as directed.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use in conjunction with liniments, balms or lotions.
  • Do not use on damaged or broken skin.

Stop use and ask a doctor if
  • Redness is present.
  • Excessive irritation of skin develops.
  • Condition worsens, or if symptoms persist for more than 7 days.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

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

Directions

Open pouch and remove. Pull woven sleeve containing external analgesic pads over ankle, positioning on either side of affected area.

  • Adults and children 3 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
  • Children under 3 years of age: Consult a physician.

Other information:
  • Store away from direct sunlight.
  • For your protection, this sleeve has been sealed in an aluminum pouch.
  • Do not use if tamper evident seal is missing, tampered, broken or destroyed.

Allergy warning:

Contains Macadamia nut oil.

Inactive ingredients

Macadamia nut oil, citronella oil, mandarin oil, coriander oil and rosemary oil.

Questions?:

000-000-0000

SmartRx Natural Pain Relief Sleeve KNEE 1 count (60589-004-00)

SMARTRX NATURAL PAIN RELIEF SLEEVE KNEE 
methyl salicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60589-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MACADAMIA OIL 
CITRONELLA OIL 
MANDARIN OIL 
CORIANDER OIL 
ROSEMARY OIL 
Packaging
#Item CodePackage Description
1NDC:60589-004-001 PACKAGE (PACKAGE) in 1 BOX
10.2 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/27/2013
Labeler - Niche Brands, Inc. (079208100)
Establishment
NameAddressID/FEIOperations
AB7 Industries381206077manufacture(60589-004)

Revised: 12/2013
 
Niche Brands, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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