PAIN RELIEF SIGNATURE CARE- menthol 10.5% spray 
Better Living Brands

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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Drug Facts

Active ingredient                                                            Purpose
Menthol 10.5%..............................................................Topical Analgesic

Uses Temporary relief from minor aches and pains of sore 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 the eyes or mucous
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, or if symptoms
persist for more than 7 days, or clear up and reoccur.

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

Directions • 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 physician.

Inactive ingredients Alcohol Denat., Arnica Montana Flower
Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf
Extract, Chamomile Recutita Flower Extract, Dimethyl Sulfone, Echinacea
Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate,
Juniperus Communis Fruit Extract, Water

image description

PAIN RELIEF  SIGNATURE CARE
menthol 10.5% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol10.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
JUNIPER BERRY (UNII: O84B5194RL)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-333-0385 g in 1 CAN; Type 0: Not a Combination Product03/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/30/2018
Labeler - Better Living Brands (009137209)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(21130-333) , label(21130-333)

Revised: 1/2018
Document Id: de20b317-312f-4c2f-960f-f6e982006aae
Set id: 49d2823a-7310-40ba-aecf-5057663bf9a7
Version: 1
Effective Time: 20180122
 
Better Living Brands