FDA.reportPublic FDA data

Instaflex Pain Relief Roll-On

Manufacturer
Healthy Directions, LLC | Pure Source, LLC
Effective date
2019-10-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:17

Label at a glance#

ProductInstaflex Pain Relief Roll-On
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with arthritis strains sprains bruises

Dosage and administration

Adult and children 12 years of age and older: Apply to affected area no more than 3-4 times daily. Children under 12 years of age: Consult a doctor.

Storage and handling

Keep product at room termperature and humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. Lot Number and Expiration Date printed below.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol (1.25%)

Purpose

OTC - PURPOSE SECTION

Menthol (1.25%)....................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with

  • arthritis
  • strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • with a heating pad, may blister skin
  • on open wounds or damaged skin

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area

OTC - WHEN USING SECTION

When using this product

  • Use only as directed
  • avoid contact with eyes
  • do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 12 years of age and older: Apply to affected area no more than 3-4 times daily.

Children under 12 years of age: Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Keep product at room termperature and humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. Lot Number and Expiration Date printed below.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Alcohol, Citrus Aurantium Dulcis (Orange) Oil, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Oil, Clyceryl Stearate SE, Oxygenated Corn Oil, Phenoxyethanol, Polysorbate-20, Sodium Hydroxide, Steareth-20, Water, Xanthan Gum, Zemea (Corn) Propanediol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOCTOR DEVELOPED

FAST ACTING

PAIN RELIEVING ROLL-ON

Instaflex

PAIN RELIEF

Formualted with an Exclusive Oxygenated Oil

Powerful roll-on relief for arthritis, joint & muscle pain

  • Deep Penetrating
  • Fast Acting
  • Pleasant Smelling
  • Non-Greasy
  • No Mess

Net wt. 2.5 oz (71 g)

InstaFlexInstaFlex

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70015-670-252023-01-30C16284748780-1f386c64a-3bc0-0266-e053-dadaa90a7c1aInstaFlex Pain Relieving Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70015-670-25Instaflex Pain Relief Roll-On1 in 1 CARTONLIQUID11
70015-670-25Instaflex Pain Relief Roll-On71 g in 1 BOTTLE, WITH APPLICATORLIQUID711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70015-670INSTAFLEX PAIN RELIEF ROLL-ON (MENTHOL) LIQUID [HEALTHY DIRECTIONS, LLC]1Legacy NDC, 2 package rows20191023_957686cc-43ec-6163-e053-2a95a90ad430.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70015-67070015-670-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CORN OIL8470G57WFMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARETH-20L0Q8IK9E08IACT
WATER059QF0KO0RIACT
ORANGE OILAKN3KSD11BIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
XANTHAN GUMTTV12P4NEEIACT
PROPANEDIOL5965N8W85TIACT
MENTHOLL7T10EIP3AACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT

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
957686cc-43ed-6163-e053-2a95a90ad430957686cc-43ec-6163-e053-2a95a90ad4302019-10-21WarningsExact identifier
spl id: 957686cc-43ed-6163-e053-2a95a90ad430
spl set id: 957686cc-43ec-6163-e053-2a95a90ad430

Reported adverse events (FAERS/openFDA)#

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