PAINFIX RESTORE- menthol patch

PainFix Restore by

Drug Labeling and Warnings

PainFix Restore 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 3%

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:

• open pouch and remove patch
• peel off protective backing and carefully apply sticky side to affected area
• if affected area is large, use more than one patch for best results
• use each patch for up to 15 hours
• apply a new patch each day
• to better keep the patch in place, use the provided adhesive plasters
• for best results, use with recommended exercises

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, Aluminum glycinate, Angelica anomala extract, Carthamus tinctorius extract, Cinnamomum camphora extract, Cinnamomum cassia extract, Citrus reticulata extract, Commiphora molmol extract, Curcuma longa extract, Curcuma zedoaria extract, Daemonops draco extract, Disodium EDTA, Drynaria fortunei extract, Glycerine, Glyceryl stearate, Kaolin, Methylparaben, PEG-40 hydrogenated castor oil, Pistacia lentiscus extract, Polyvinylpyrrolidone, Rheum officinale extract, Sodium polyacrylate, Scutellaria baicalenis extract, Tartaric acid, Water (Aqua)

Package Labeling:

INGREDIENTS AND APPEARANCE

PAINFIX RESTORE 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72749-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
TURMERIC (UNII: 856YO1Z64F)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72749-000-00	5 in 1 BOX	02/01/2019
1		1 in 1 PACKET
1		573 mL in 1 PATCH; 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)