FDA.reportPublic FDA data

Zurflex

Manufacturer
Basler Health Care Group | TAKA USA Inc. dba Cosmetic Inoovations
Effective date
2020-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:07:19

Label at a glance#

ProductZurflex
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves minor pain associated with simple backache arthritis tendonitis strains sprains pulled ligaments sore/stiff muscles sports injuries

Dosage and administration

repeat as necessary but no more than 4 times daily Children 2 years or younger ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 9%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional; before use

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • repeat as necessary but no more than 4 times daily

Children 2 years or younger ask a doctor

Flammable

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Eucalyptus Oil, isopropyl alcohol, Spearmint Oil, Water

Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle LabelBottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72668-001-012024-01-30C16284748780-11030e365-12e7-111a-e063-dadaa90a10e2b3eed442-4345-6cd3-e053-2995a90a59dd

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72668-00172668-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
SPEARMINT OILC3M81465G5IACT
EUCALYPTUS OIL2R04ONI662IACT
MENTHOLL7T10EIP3AACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b3eed442-4346-6cd3-e053-2995a90a59ddb3eed442-4345-6cd3-e053-2995a90a59dd2020-11-12WarningsExact identifier
spl id: b3eed442-4346-6cd3-e053-2995a90a59dd
spl set id: b3eed442-4345-6cd3-e053-2995a90a59dd

Reported adverse events (FAERS/openFDA)#

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