Instaflex Pain Relief Cream

Instaflex Pain Relief Cream
SPL v2
SPL
SPL Set ID 665b847a-9cfb-49fc-975b-81c97f936575
Route
TOPICAL
Published
Effective Date 2019-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (12.5 mg)
Inactive Ingredients
C13-14 Isoparaffin Orange Oil Ethylhexylglycerin Eucalyptus Oil Glyceryl Monostearate Laureth-7 Corn Oil Peg-100 Stearate Phenoxyethanol Polyacrylamide (crosslinked; 0.01-0.2 Mole Percent Bisacrylamide) Polysorbate 20 Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-01-01

Description

Drug Facts 


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses  Temporarily relieves minor aches and pains

of muscles and joints associated with 

  • simple backache
  • arthritis 
  • strains 
  • sprains 
  • bruises
Dosage and Administration

Directions 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.

Description

Drug Facts 

Section 42229-5

Drug Facts 

Section 50565-1

Keep out of reach of children. 

If swallowed, get medical help or contact a Poison Control Center right away. 

Section 50566-9

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 
Section 50567-7

When using this product

  • Use only as directed 
  • avoid contact with eyes 
  • do not bandage tightly
Section 50569-3

Ask a doctor before use if you have

redness over the affected area

Section 50570-1

Do not use

  • with a heating pad, may blister skin
  • on open wounds or damaged skin 
Section 51727-6

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 

Section 51945-4

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)

Section 55105-1

Purpose

Topical Analgesic 

Section 55106-9

Active Ingredient

Menthol (1.25%)

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. 


Structured Label Content

Indications and Usage (34067-9)

Uses  Temporarily relieves minor aches and pains

of muscles and joints associated with 

  • simple backache
  • arthritis 
  • strains 
  • sprains 
  • bruises
Dosage and Administration (34068-7)

Directions 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.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts 

Section 50565-1 (50565-1)

Keep out of reach of children. 

If swallowed, get medical help or contact a Poison Control Center right away. 

Section 50566-9 (50566-9)

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 
Section 50567-7 (50567-7)

When using this product

  • Use only as directed 
  • avoid contact with eyes 
  • do not bandage tightly
Section 50569-3 (50569-3)

Ask a doctor before use if you have

redness over the affected area

Section 50570-1 (50570-1)

Do not use

  • with a heating pad, may blister skin
  • on open wounds or damaged skin 
Section 51727-6 (51727-6)

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 

Section 51945-4 (51945-4)

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)

Section 55105-1 (55105-1)

Purpose

Topical Analgesic 

Section 55106-9 (55106-9)

Active Ingredient

Menthol (1.25%)

Other Information  (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. 


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