PAINFIX RESTORE- menthol patch 
PainFix 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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PainFix Restore Patch

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:

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:

Label

PAINFIX RESTORE 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72749-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72749-000-005 in 1 BOX02/01/2019
11 in 1 PACKET
1573 mL in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2019
Labeler - PainFix LLC (116908667)

Revised: 2/2019
Document Id: 822e1fe3-ee52-213c-e053-2991aa0a3e35
Set id: 3838ecd0-4b5b-4c68-8995-33b5c27718be
Version: 2
Effective Time: 20190218
 
PainFix LLC