PAINFIX RELIEF- menthol gel

PainFix Relief by

Drug Labeling and Warnings

PainFix Relief by is a Otc medication manufactured, distributed, or labeled by PainFix LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol 5%

Purpose

`Topical analgesic

Uses

temporarily relieves aches and pains of joints and muscles associated with:  backache  arthritis  bursitis  tendonits  cramps  strains  bruises  sprains

Warnings

Avoid direct contact with eyes. For external use only.

When using this product

use only as directed  avoid contact with eyes or mucous membranes  do not apply local heat to the area of use  do not apply to wounds, broken, damaged or irritated skin

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days  skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

Directions

Adults and children above 12 years:

• apply gel to affected area(s) and massage gently until thoroughly absorbed into skin
• repeat up to 3 to 4 times per day, on an as needed basis
• after applying, wash hands with soap and water

Children 12 years and younger, ask a health professional

Other Information

Store in a cool, dry place, away from direct sunlight.

Ingredients

Aloe barbadensis extract, Angelica anomala extract, Caprylyl glycol (and) Phenethyl alcohol, Carbomer, Carthamus tinctorius extract, Cinnamomum camphora extract, Cinnamomum cassia extract, Citrus reticulata extract, Commiphora molmol extract, Curcuma longa extract,
Curcuma zedoaria extract, Daemonops draco extract, Drynaria fortunei extract, Glycerin, Pistacia lentiscus extract, Propylene glycol, Rheum officinale extract, Scutellaria baicalenis extract, Water (Aqua)

Package Labeling:

INGREDIENTS AND APPEARANCE

PAINFIX RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72749-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TURMERIC (UNII: 856YO1Z64F)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72749-001-00	1 in 1 BOX	02/01/2019
1		60 g in 1 TUBE; 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	02/01/2019

Labeler - PainFix LLC (116908667)