PAIN RELIEF ROLLER SIGNATURE CARE- menthol 4% gel

Pain Relief Roller by

Drug Labeling and Warnings

Pain Relief Roller by is a Otc medication manufactured, distributed, or labeled by Better Living, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Uses

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

WARNINGS

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 membranesdo 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

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

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF ROLLER  SIGNATURE CARE
menthol 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-764
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-764-03	73 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	03/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/30/2018

Labeler - Better Living (009137209)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(21130-764) , label(21130-764)