KINeSYS description, usages, side effects, indications, overdosage, supplying and lots more!

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KINeSYS

KINeSYS Pharmaceutical Inc.

Analgesic Sport Stick


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

KINeSYS

METHYL SALICYLATE and MENTHOL STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61481-0020
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
methyl salicylate METHYL SALICYLATE 30 g
MENTHOL 15 g

Inactive Ingredients

Ingredient Name Strength
propylene glycol
polyethylene glycol 400
ALCOHOL
sodium stearate
water
D&C GREEN NO. 5

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61481-0020-1 50 in 1 CYLINDER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2012-05-31


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