MEDISTIK COOLING ROLL-ON

Manufacturer: Medistik Inc
Effective date: 2020-05-26
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:14:41

Label at a glance#

ProductMEDISTIK COOLING ROLL-ON

Active ingredientMENTHOL, CAMPHOR OIL

Label structure8 sections

Indications and uses

For the temporary relief of sore muscles and joints associated with simple backache arthritis strains sprains bruises cramps

Dosage and administration

For use on adults and children over 12 years of age and older: Apply product on affected area, not more than 4 times daily children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Camphor 4%

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

USES

INDICATIONS & USAGE SECTION

For the temporary relief of sore muscles and joints associated with

simple backache
arthritis
strains
sprains
bruises
cramps

WARNINGS

WARNINGS SECTION

When using this product

use only as directed
avoid getting into the eyes and mucous membranes
do not bandage tightly or use with a heating pad
do not apply to wounds or damaged skin

Stop use and ask doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
excessive skin irritation or redness occurs

If pregnant or breast-feeding, ask a health professional before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

For use on adults and children over 12 years of age and older: Apply product on affected area, not more than 4 times daily
children under 12 years of age: ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Denatured alcohol, Water, Peppermint oil, Glycerin, Polyacrylate Crosspolymer-6, MSM, Ilex paraguariensis leaf extract, Glucosamine sulphate, Chondroitin sulphate, Folic acid, Vitamin C, Vitamin D.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_MediStik Roll-on

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2370887	camphor 4 % / menthol 10 % Topical Solution	PSN	4
2370887	camphor 40 MG/ML / menthol 100 MG/ML Topical Solution	SCD	4
2370887	camphor 4 % / menthol 10 % Topical Solution	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77108-103-11	2022-01-28	C162847	48780-1	d6a99b39-8ca1-a426-e053-dadaa90af4c2	MEDISTIK COOLING ROLL-ON

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77108-103-11	MEDISTIK COOLING ROLL-ON	89 mL in 1 BOTTLE	SOLUTION	89		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77108-103	MEDISTIK COOLING ROLL-ON (MENTHOL, CAMPHOR) SOLUTION [MEDISTIK INC]	4	Legacy NDC, 1 package rows	20200527_a0715881-66db-4203-80ae-823013ac3fcf.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

MEDISTIK COOLING ROLL-ON
MENTHOL, CAMPHOR
MENTHOL
CAMPHOR OIL
ALCOHOL
WATER
PEPPERMINT OIL
GLYCERIN
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)
DIMETHYL SULFONE
ILEX PARAGUARIENSIS LEAF
GLUCOSAMINE SULFATE
CHONDROITIN SULFATE (CHICKEN)
FOLIC ACID
ASCORBIC ACID
VITAMIN D

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77108-103	77108-103-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
CAMPHOR OIL	75IZZ8Y727	ACTIB
ALCOHOL	3K9958V90M	IACT
WATER	059QF0KO0R	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
GLYCERIN	PDC6A3C0OX	IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)	Q7UI015FF9	IACT
DIMETHYL SULFONE	9H4PO4Z4FT	IACT
ILEX PARAGUARIENSIS LEAF	1Q953B4O4F	IACT
GLUCOSAMINE SULFATE	1FW7WLR731	IACT
CHONDROITIN SULFATE (CHICKEN)	7VZ9466BAB	IACT
FOLIC ACID	935E97BOY8	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
VITAMIN D	9VU1KI44GP	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
59828743-fd4a-4633-a726-5c5fc820dd13			a0715881-66db-4203-80ae-823013ac3fcf	2020-05-26	Warnings	Exact identifier spl id: 59828743-fd4a-4633-a726-5c5fc820dd13 spl set id: a0715881-66db-4203-80ae-823013ac3fcf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.