PAIN RELIEF ROLLER SIGNATURE CARE- menthol 4% gel 
Better Living

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.

----------

Drug Facts

Active ingredient                                                        Purpose
Menthol 4%...............................................................Topical anesthetic

Uses

For the temporary relief from minor aches and pains of soar muscles and joints associated with arthritis, backache, strains and sprains

Warnings
For external use only.

Flammable: Do not use while smoking or near heat or flame
When using this product  • avoid contact with eyes or mucouse membranes•do not apply to wounds or damaged skin • do not apply to the irritated skin • do not bandage • wash hands after use with cool water • do not use with heating pad or device.

Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within
a few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Directions
Shake well. Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of
age: consult a doctor.

Inactive ingredients

Aloe Barbadensis Leaf Extract
Arctium Lappa Root (Burdock) Extract
Arnica Montana Flower Extract
Boswellia Carterii Resin Extract
Calendula Officinalis Extract
Camellia Sinensis Leaf Extract
Camphor
Carbomer
FD&C Blue #1
FD&C Yellow #5
Glycerin
Ilex Paraguariensis (Mate) Leaf Extract
Isopropyl Alcohol
Isopropyl Myristate
Melissa Officinalis (Lemon Balm) Leaf Extract
Silica
Tocopheryl Acetate
Triethanolamine
Water

image description

PAIN RELIEF ROLLER  SIGNATURE CARE
menthol 4% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-764
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
Glycerin (UNII: PDC6A3C0OX)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
Isopropyl Alcohol (UNII: ND2M416302)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-764-0373 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package03/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/30/2018
Labeler - Better Living (009137209)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(21130-764) , label(21130-764)

Revised: 1/2018
Document Id: de55d3c9-dffb-4889-b7f5-f7ba5f10b99f
Set id: 01ab3464-256a-4caa-9efb-c30c98dbe102
Version: 1
Effective Time: 20180118
 
Better Living