Zurflex by Basler Health Care Group / TAKA USA Inc. dba Cosmetic Inoovations

Drug Details [pdf]

ZURFLEX- pain relief spray spray
Basler Health Care Group

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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Active Ingredient

Menthol 9%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with

simple backache
arthritis
tendonitis
strains
sprains
pulled ligaments
sore/stiff muscles
sports injuries

Warnings

For external use only

When using this product

use only as directed
avoid contact with eyes
do not apply to open wounds or damaged skin
do not bandage tightly or use a heat pad

Stop use and ask a doctor if

condition worsens or if symptoms persist for more than 7 days
irritation develops
redness is present

If pregnant or breast-feeding

ask a health professional; before use

Keep out of the reach of children

If accidentally ingested, seek medical help or contact a Poison Control Center immediately, Replace cap firmly.

Directions

repeat as necessary but no more than 4 times daily

Children 2 years or younger ask a doctor

Flammable

Do not use near flame or heated surface. Store at room temperature.

Inactive Ingredients

Eucalyptus Oil, isopropyl alcohol, Spearmint Oil, Water

Bottle Label

ZURFLEX
pain relief spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72668-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	90 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
SPEARMINT OIL (UNII: C3M81465G5)
EUCALYPTUS OIL (UNII: 2R04ONI662)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 72668-001-01	237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/01/2020

Labeler - Basler Health Care Group (794923128)

Name	Address	ID/FEI	Business Operations
Establishment
TAKA USA Inc. dba Cosmetic Inoovations		802860515	manufacture(72668-001)

Revised: 11/2020

Document Id: b3eed442-4346-6cd3-e053-2995a90a59dd

Set id: b3eed442-4345-6cd3-e053-2995a90a59dd

Version: 1

Effective Time: 20201112

Trademark Results [Zurflex]

Mark Image Registration \| Serial	Company Trademark Application Date
ZURFLEX 90246524 not registered Live/Pending	Basler Health Care Group, Inc. 2020-10-10