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

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

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

Bottle Label

ZURFLEX 
pain relief spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72668-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL90 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
SPEARMINT OIL (UNII: C3M81465G5)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72668-001-01237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2020
Labeler - Basler Health Care Group (794923128)
Establishment
NameAddressID/FEIBusiness Operations
TAKA USA Inc. dba Cosmetic Inoovations802860515manufacture(72668-001)

Revised: 11/2020
Document Id: b3eed442-4346-6cd3-e053-2995a90a59dd
Set id: b3eed442-4345-6cd3-e053-2995a90a59dd
Version: 1
Effective Time: 20201112
 
Basler Health Care Group