FDA.reportPublic FDA data

Instaflex Extra Strength Pain Relief Cream

Manufacturer
Healthy Directions, LLC | Pure Source, LLC
Effective date
2026-05-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:57:03

Label at a glance#

ProductInstaflex Extra Strength Pain Relief Cream
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure9 sections

Storage and handling

Other Information 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 Ingredients

Menthol (2.5%)

Methyl Salicylate (10%) 

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

Directions Adults 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 SECTION

Other InformationKeep 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

EXTRA STRENGTH PAIN RELIEVING CREAM

Instaflex 

PAIN RELIEF

Formulated with an 

EXCLUSIVE OXYGENATED OIL 

FAST, EXTRA STRENGTH RELIEF FOR

ARTHRITIS, JOINT & MUSCLE PAIN 

DOUBLE THE PAIN-FIGHTING INGREDIENTS

DOUBLE THE MENTHOL POWER*

Deep Penetrating |  Fast Acting |  Great for Nighttime Use 

EXTRA STRENGTH | DOCTOR DEVELOPED 

Net wt. [2/4] oz ([57/113] g) 

2oz Carton2oz Carton

2oz Tube2oz Tube

4oz Carton4oz Carton

4oz Tube4oz Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148131menthol 2.5 % / methyl salicylate 10 % Topical CreamPSN2
1148131menthol 25 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130678829292458GTIN-13: 0678829292458
EAN-13: 0678829292458
GTIN-12: 678829292458
UPC-A: 678829292458
GTIN storage (14 digits): 00678829292458		Instaflex ES 2oz Tube.jpg
BarcodeEAN-130678829292465GTIN-13: 0678829292465
EAN-13: 0678829292465
GTIN-12: 678829292465
UPC-A: 678829292465
GTIN storage (14 digits): 00678829292465		Instaflex ES 4oz. Tube.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70015-660-022024-01-30C16284748780-11030e365-39cc-111a-e063-dadaa90a10e2Instaflex Extra Strength Pain Relief Cream
70015-660-042024-01-30C16284748780-11030e365-39cc-111a-e063-dadaa90a10e2Instaflex Extra Strength Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70015-660-02Instaflex Extra Strength Pain Relief Cream57 g in 1 TUBECREAM572
70015-660-02Instaflex Extra Strength Pain Relief Cream1 in 1 CARTONCREAM12
70015-660-04Instaflex Extra Strength Pain Relief Cream1 in 1 CARTONCREAM12
70015-660-04Instaflex Extra Strength Pain Relief Cream113 g in 1 TUBECREAM1132

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
70015-66070015-660-02, 70015-660-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
METHYL SALICYLATELAV5U5022YACTIB

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 Extra Strength Pain Relief CreamMENTHOL, METHYL SALICYLATEHealthy Directions, LLCd058c64d-0e4f-45aa-8f52-804961b562e32026-05-11WarningsExact identifier
ndc (package): 70015-660-04
ndc (package): 70015-660-02
ndc (product): 70015-660
ndc11 (package): 70015066002
ndc11 (package): 70015066004
spl id: 5190500c-53c7-a68a-e063-6394a90a52a9
spl set id: d058c64d-0e4f-45aa-8f52-804961b562e3

Reported adverse events (FAERS/openFDA)#

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