INSTAFLEX PAIN RELIEF ROLL-ON- menthol liquid

Instaflex Pain Relief Roll-On by

Drug Labeling and Warnings

Instaflex Pain Relief Roll-On by is a Otc medication manufactured, distributed, or labeled by Healthy Directions, LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• arthritis
• strains
• sprains
• bruises

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

PRINCIPAL DISPLAY PANEL

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

• Deep Penetrating
• Fast Acting
• Pleasant Smelling
• Non-Greasy
• No Mess

Net wt. 2.5 oz (71 g)

INGREDIENTS AND APPEARANCE

INSTAFLEX PAIN RELIEF ROLL-ON 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70015-670
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	12.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70015-670-25	1 in 1 CARTON	10/21/2019
1		71 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/21/2019

Labeler - Healthy Directions, LLC (150261183)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(70015-670)