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NDC 61481-0020-01 KINeSYS 15; 30 g/100g; g/100g Details

KINeSYS 15; 30 g/100g; g/100g

KINeSYS is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by Wilc Healthcare Inc. The primary component is MENTHOL; METHYL SALICYLATE.

Product Information

NDC	61481-0020
Product ID	61481-0020_5a1d61c8-41ac-4aae-b4bb-2aaef581ff82
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	KINeSYS
Proprietary Name Suffix	Analgesic Sport
Non-Proprietary Name	METHYL SALICYLATE and MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	15; 30
Active Ingredient Units	g/100g; g/100g
Substance Name	MENTHOL; METHYL SALICYLATE
Labeler Name	Wilc Healthcare Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 61481-0020-01 (61481002001)

Pricing Information	N/A
NDC Package Code	61481-0020-1
Billing NDC	61481002001
Package	50 g in 1 CYLINDER (61481-0020-1)
Marketing Start Date	2012-05-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c1d58e0c-a66d-48d0-b1c3-cb0546595b42 Details

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.

SPL UNCLASSIFIED SECTION

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

Principal Display Panel - 50 g Cylinder Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61481-0020-1	50 g in 1 CYLINDER; Type 0: Not a Combination Product	05/31/2012

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

Labeler - Wilc Healthcare Inc (203499140)

Registrant - Wilc Healthcare Inc (203499140)

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

Revised: 9/2019

Document Id: 5a1d61c8-41ac-4aae-b4bb-2aaef581ff82

Set id: c1d58e0c-a66d-48d0-b1c3-cb0546595b42

Version: 2

Effective Time: 20190920