INSTAFLEX PAIN RELIEF- menthol, methyl salicylate spray 
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 Spray

Drug Facts

Active Ingredients

Menthol (5%)

Methyl Salicylate (10%)

Purpose

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

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

Uses

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

Warnings

For external use only

Flammable

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)

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 and mucous membrane
  • avoid inhalation of fumes
  • spray away from face
  • 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: 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

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

Inactive ingredients

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

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

EXTRA STRENGTH

PAIN RELIEVING SPRAY

Net wt. 4.0 oz (113 g)

AH_IPRESS_4oz_CARTON

INSTAFLEX PAIN RELIEF 
menthol, methyl salicylate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70015-675
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CORN OIL (UNII: 8470G57WFM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ORANGE OIL (UNII: AKN3KSD11B)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70015-675-401 in 1 CARTON12/11/2019
1113 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/11/2019
Labeler - Healthy Directions, LLC (150261183)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(70015-675)

Revised: 12/2019
Document Id: 997666e2-95e4-3c93-e053-2995a90a55ae
Set id: 997650f9-7f03-64de-e053-2995a90a617b
Version: 1
Effective Time: 20191211
 
Healthy Directions, LLC