FDA.reportPublic FDA data

Instaflex Pain Relief Cream

Manufacturer
Adaptive Health, LLC | Pure Source, LLC
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:02

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

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. 

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 

Proud Partner of the 

Arthritis

Foundation 

POWEFUL 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) 

2 oz Tube2 oz Tube

2 oz Carton2 oz Carton

4 oz Tube4 oz Tube

4 oz Carton4 oz Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416982menthol 1.25 % Topical CreamPSN1
416982menthol 12.5 MG/ML Topical CreamSCD1
416982menthol 1.25 % Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72779-100-02Instaflex Pain Relief Cream57 g in 1 TUBECREAM571
72779-100-02Instaflex Pain Relief Cream1 in 1 CARTONCREAM11
72779-100-04Instaflex Pain Relief Cream113 g in 1 TUBECREAM1131
72779-100-04Instaflex Pain Relief Cream1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72779-100INSTAFLEX PAIN RELIEF CREAM (MENTHOL) CREAM [ADAPTIVE HEALTH, LLC]1Current NDC, Legacy NDC, 4 package rows20190101_911f5021-a851-444e-8c2a-2be4fa94e828.zip

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
72779-10072779-100-02, 72779-100-04

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
MENTHOLL7T10EIP3AACTIB
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

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 CreamMENTHOLAdaptive Health, LLC911f5021-a851-444e-8c2a-2be4fa94e8282018-12-21WarningsExact identifier
ndc (package): 72779-100-02
ndc (package): 72779-100-04
ndc (product): 72779-100
ndc11 (package): 72779010004
ndc11 (package): 72779010002
spl id: e7dfe524-438c-45e8-b652-fa625f72bc79
spl set id: 911f5021-a851-444e-8c2a-2be4fa94e828

Reported adverse events (FAERS/openFDA)#

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