INSTAFLEX PAIN RELIEF ROLL-ON- menthol liquid 
Healthy Directions, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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InstaFlex Pain Relieving Roll-On

Drug Facts

Active Ingredient

Menthol (1.25%)

Purpose

Menthol (1.25%)....................Topical Analgesic

Uses

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

Warnings

For external use only

Do not use

  • with a heating pad, may blister skin
  • on open wounds or damaged skin

Ask a doctor before use if you have redness over the affected area

When using this product

  • Use only as directed
  • avoid contact with eyes
  • do not bandage tightly

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other information

Keep product at room termperature and humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. Lot Number and Expiration Date printed below.

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Alcohol, Citrus Aurantium Dulcis (Orange) Oil, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Oil, Clyceryl Stearate SE, Oxygenated Corn Oil, Phenoxyethanol, Polysorbate-20, Sodium Hydroxide, Steareth-20, Water, Xanthan Gum, Zemea (Corn) Propanediol

DOCTOR DEVELOPED

FAST ACTING

PAIN RELIEVING ROLL-ON

Instaflex

PAIN RELIEF

Formualted with an Exclusive Oxygenated Oil

Powerful roll-on relief for arthritis, joint & muscle pain

Net wt. 2.5 oz (71 g)

InstaFlex

INSTAFLEX PAIN RELIEF ROLL-ON 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70015-670
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CORN OIL (UNII: 8470G57WFM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARETH-20 (UNII: L0Q8IK9E08)  
WATER (UNII: 059QF0KO0R)  
ORANGE OIL (UNII: AKN3KSD11B)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PROPANEDIOL (UNII: 5965N8W85T)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70015-670-251 in 1 CARTON10/21/2019
171 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/21/2019
Labeler - Healthy Directions, LLC (150261183)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(70015-670)

Revised: 10/2019
Document Id: 957686cc-43ed-6163-e053-2a95a90ad430
Set id: 957686cc-43ec-6163-e053-2a95a90ad430
Version: 1
Effective Time: 20191021
 
Healthy Directions, LLC