FDA.reportPublic FDA data

Instaflex Pain Relief Cream

Manufacturer
Healthy Directions, LLC | Pure Source, LLC
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:56:56

Label at a glance#

ProductInstaflex Pain Relief Cream
Active ingredientMENTHOL
Label structure9 sections

Storage and handling

Keep product at room termperature and humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. For Lot Number and Expiration Date, see crimp at end of tube. 

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts 

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Menthol (1.25%)

OTC - PURPOSE SECTION

Purpose

Topical Analgesic 

INDICATIONS & USAGE SECTION

Uses Temporarily relieves minor aches and pains

of muscles and joints associated with 

  • simple backache
  • arthritis 
  • strains 
  • sprains 
  • bruises

WARNINGS SECTION

Warnings

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. 

DOSAGE & ADMINISTRATION SECTION

DirectionsAdult 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. For Lot

Number and Expiration Date, see crimp at end of tube. 

INACTIVE INGREDIENT SECTION

Inactive ingredients C13-14 Isoparaffin, Citrus Aurantium

Dulcis (Orange) Oil, Ethylhexlglycerin, Eucalyptus Globulus Oil,

Glyceryl Stearate, Laureth-7, Oxygenated Corn Oil, PEG-100

Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Water 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PAIN RELIEVING CREAM  

Instaflex

PAIN RELIEF

Formulated with an 

EXCLUSIVE OXYGENATED OIL 

FAST RELIEF FOR ARTHRITIS,

JOINT & MUSCLE PAIN 

POWERFUL PAIN RELIEF STARTS IN MINUTES,

LASTS FOR HOURS 

Deep Penetrating |  Fast Acting |  Pleasant Smelling |  Non-Greasy 

CLINICALLY STUDIED | DOCTOR DEVELOPED 

Net wt. [2/4] oz ([57/113] g)

2oz Tube2oz Tube

2oz Carton2oz Carton

4oz Tube4oz Tube

4oz Carton4oz Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416982menthol 1.25 % Topical CreamPSN3
416982menthol 12.5 MG/ML Topical CreamSCD3
416982menthol 1.25 % Topical CreamSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130678829292427GTIN-13: 0678829292427
EAN-13: 0678829292427
GTIN-12: 678829292427
UPC-A: 678829292427
GTIN storage (14 digits): 00678829292427		2oz Tube.jpg
BarcodeEAN-130678829292434GTIN-13: 0678829292434
EAN-13: 0678829292434
GTIN-12: 678829292434
UPC-A: 678829292434
GTIN storage (14 digits): 00678829292434		4 oz Tube.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70015-665-012024-01-30C16284748780-11030e365-35e7-111a-e063-dadaa90a10e2Instaflex Pain Relief Cream
70015-665-022024-01-30C16284748780-11030e365-35e7-111a-e063-dadaa90a10e2Instaflex Pain Relief Cream
70015-665-042024-01-30C16284748780-11030e365-35e7-111a-e063-dadaa90a10e2Instaflex Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70015-665-01Instaflex Pain Relief Cream28 g in 1 TUBECREAM283
70015-665-01Instaflex Pain Relief Cream1 in 1 CARTONCREAM13
70015-665-02Instaflex Pain Relief Cream1 in 1 CARTONCREAM13
70015-665-02Instaflex Pain Relief Cream57 g in 1 TUBECREAM573
70015-665-04Instaflex Pain Relief Cream113 g in 1 TUBECREAM1133
70015-665-04Instaflex Pain Relief Cream1 in 1 CARTONCREAM13

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70015-66570015-665-02, 70015-665-04, 70015-665-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
C13-14 ISOPARAFFINE4F12ROE70IACT
ORANGE OILAKN3KSD11BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LAURETH-7Z95S6G8201IACT
CORN OIL8470G57WFMIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)RHA9LWJ494IACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
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
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
ndc (package): 70015-665-04
ndc (package): 70015-665-02
ndc (package): 70015-665-01
ndc (product): 70015-665
ndc11 (package): 70015066502
ndc11 (package): 70015066501
ndc11 (package): 70015066504
spl id: 51a0db5e-9e53-71c2-e063-6394a90a1bb2
spl set id: 665b847a-9cfb-49fc-975b-81c97f936575

Reported adverse events (FAERS/openFDA)#

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