KINeSYS Analgesic Sport

Dosage form: stick
Ingredients: METHYL SALICYLATE 30g in 100g, MENTHOL 15g in 100g
Labeler: KINeSYS Pharmaceutical Inc.
NDC Code: 61481-0020

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.

Analgesic Sport Stick

RECOMMENDED USE

Temporarily relieves aches and pains of muscles and joints associated with one or more of the following: backache, strains and sprains (involving muscles, tendons, and/or ligaments), and arthritis.

DURATION OF USE

Consult a health care practitioner for use beyond 7 days.

  • Store protected from direct light and moisture at room temperature.

MEDICINAL INGREDIENTS (PER DOSE UNIT)

Methyl salicylate 30%, Menthol (l-Menthol, Mentha arvensis - Herb top) 15%.

NON-MEDICINAL INGREDIENTS

Propylene glycol, PEG-8, Ethyl alcohol, Sodium stearate, Aqua, D&C Green No. 5.

RECOMMENDED DOSE

Adults, adolescents

1-4 time(s) per day. Apply thinly and evenly to affected area up to 3 to 4 times per day. Rub and/or massage into skin until solution vanishes. For external use only. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.

Children 2-12 years old

1-4 time(s) per day. Application should be supervised by an adult. Apply thinly and evenly to affected area up to 3 to 4 times per day. Rub and/or massage into skin until solution vanishes. For external use only. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.

CAUTIONS AND WARNINGS

Keep out of the reach of children.

If overdose or accidental ingestion occurs, call a Poison Control Center immediately.

Discontinue use and consult a health care practitioner if symptoms persist and/or worsen after 7 days or re-occur within a few days.

Consult a healthcare practitioner prior to use if you are pregnant or breastfeeding .

Consult a healthcare practitioner prior to use if you are taking anticoagulant medications.

Store protected from direct light and moisture at room temperature.

KNOWN ADVERSE REACTIONS

Rashes and/or burning discomfort have been known to occur; in which case, discontinue use. Hypersensitivity such as allergy has been known to occur; in which case, discontinue use.

PRINCIPAL DISPLAY PANEL - 50 g Cylinder Label

KINeSYS®

Analgesic
SPORT STICK

  • penetrating warm PAIN RELIEF
    for muscular and arthritic discomfort

extra strength MUSCLE CARE

Topical

Hands-free applicator

50 g (1.76 OZ)

NPN 80029329

KINESYS  ANALGESIC SPORT
methyl salicylate and menthol stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-0020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE30 g  in 100 g
MENTHOL (MENTHOL) MENTHOL15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
POLYETHYLENE GLYCOL 400 
ALCOHOL 
SODIUM STEARATE 
WATER 
D&C GREEN NO. 5 
Packaging
#Item CodePackage Description
1NDC:61481-0020-150 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/31/2012
Labeler - KINeSYS Pharmaceutical Inc. (252292719)

Revised: 06/2012
 
KINeSYS Pharmaceutical 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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