FDA.reportPublic FDA data

InstaFlex Pain Relieving Spray

Manufacturer
Healthy Directions, LLC | Pure Source, LLC
Effective date
2019-12-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:00

Label at a glance#

ProductInstaflex Pain Relief
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure8 sections

Indications and uses

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

Dosage and administration

Adult and children 12 years of age and older: Shake and apply liberally at least 4 inches away from affected area no more than 3-4 times daily. Let dry or rub in for greater efficacy. Children under 12 years of age: Consult a doctor.

Storage and handling

Do not freeze. For Lot Number and Expiration Date, see bottom of can.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol (5%)

Methyl Salicylate (10%)

Purpose

OTC - PURPOSE SECTION

Menthol (5%)....................Topical Analgesic

Methyl Salicylate (10%)....................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only

Flammable

SAFE HANDLING WARNING SECTION

Flammable

  • do not use near heat or flame or while smoking
  • avoid long term storage above 104F (40C)
  • do not puncture or incinerate
  • contents under pressure
  • do not store at temperature above 120F (49C)

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 and mucous membrane
  • avoid inhalation of fumes
  • spray away from face
  • 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: Shake and apply liberally at least 4 inches away from affected area no more than 3-4 times daily. Let dry or rub in for greater efficacy.

Children under 12 years of age: Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Do not freeze. For Lot Number and Expiration Date, see bottom of can.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citrus Aurantium Dulcis (Orange) Oil, Ethylhexylglycerin, Eucalyptus Globulus Oil, Methylsulfonylmethane (MSM), Oxidized Corn Oil, Phenoxyethanol, SD-Alcohol 40B.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

PAIN RELIEVING SPRAY

Instaflex

PAIN RELIEF

Formualted with an Exclusive Oxygenated Oil

Powerful, EXTRA STRENGTH, doctor-developed relief for arthritis, joint & muscle pain

  • Deep Penetrating
  • Fast Acting
  • Quick Drying
  • 360 Continuous Spray

EXTRA STRENGTH

PAIN RELIEVING SPRAY

Net wt. 4.0 oz (113 g)

AH_IPRESS_4oz_CARTONAH_IPRESS_4oz_CARTON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2266112menthol 5 % / methyl salicylate 10 % Topical SprayPSN1
2266112menthol 50 MG/ML / methyl salicylate 100 MG/ML Topical SpraySCD1
2266112menthol 5 % / methyl salicylate 10 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70015-675-402023-01-30C16284748780-1f386c649-ee87-0266-e053-dadaa90a7c1aInstaFlex Pain Relieving Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70015-675-40Instaflex Pain Relief113 g in 1 BOTTLE, SPRAYSPRAY1131
70015-675-40Instaflex Pain Relief1 in 1 CARTONSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70015-675INSTAFLEX PAIN RELIEF (MENTHOL, METHYL SALICYLATE) SPRAY [HEALTHY DIRECTIONS, LLC]1Legacy NDC, 2 package rows20191213_997650f9-7f03-64de-e053-2995a90a617b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70015-67570015-675-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CORN OIL8470G57WFMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ORANGE OILAKN3KSD11BIACT
EUCALYPTUS OIL2R04ONI662IACT
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
DIMETHYL SULFONE9H4PO4Z4FTIACT
ALCOHOL3K9958V90MIACT

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
997666e2-95e4-3c93-e053-2995a90a55ae997650f9-7f03-64de-e053-2995a90a617b2019-12-11WarningsExact identifier
spl id: 997666e2-95e4-3c93-e053-2995a90a55ae
spl set id: 997650f9-7f03-64de-e053-2995a90a617b

Reported adverse events (FAERS/openFDA)#

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