KINESYS ANALGESIC SPORT- methyl salicylate and menthol stick

KINeSYS by

Drug Labeling and Warnings

KINeSYS by is a Otc medication manufactured, distributed, or labeled by Wilc Healthcare Inc, Cosmaceutical Research Laboratory Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

STORAGE AND HANDLING

• 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

INGREDIENTS AND APPEARANCE

KINESYS  ANALGESIC SPORT
methyl salicylate and menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61481-0020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61481-0020-1	50 g in 1 CYLINDER; Type 0: Not a Combination Product	05/31/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	05/31/2012

Labeler - Wilc Healthcare Inc (203499140)

Registrant - Wilc Healthcare Inc (203499140)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmaceutical Research Laboratory Inc		256797309	manufacture(61481-0020)