KINESYS ANALGESIC SPORT- methyl salicylate and menthol stick 
Wilc Healthcare Inc

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.

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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.

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

extra strength MUSCLE CARE

Topical

Hands-free applicator

50 g (1.76 OZ)

NPN 80029329

Principal Display Panel - 50 g Cylinder Label
KINESYS  ANALGESIC SPORT
methyl salicylate and menthol stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-0020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ALCOHOL (UNII: 3K9958V90M)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
WATER (UNII: 059QF0KO0R)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61481-0020-150 g in 1 CYLINDER; Type 0: Not a Combination Product05/31/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/31/2012
Labeler - Wilc Healthcare Inc (203499140)
Registrant - Wilc Healthcare Inc (203499140)
Establishment
NameAddressID/FEIBusiness Operations
Cosmaceutical Research Laboratory Inc256797309manufacture(61481-0020)

Revised: 9/2019
Document Id: 5a1d61c8-41ac-4aae-b4bb-2aaef581ff82
Set id: c1d58e0c-a66d-48d0-b1c3-cb0546595b42
Version: 2
Effective Time: 20190920
 
Wilc Healthcare Inc