COLD THERAPY PAIN RELIEF- menthol 10.5% spray 
Kroger

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

Questions or comments? 1-800-632-6900

image description

COLD THERAPY PAIN RELIEF 
menthol 10.5% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-777
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:59450-777-0385 g in 1 CAN; Type 0: Not a Combination Product04/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/03/2018
Labeler - Kroger (006999528)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(59450-777) , label(59450-777)

Revised: 7/2018
Document Id: ebad0ba6-dd40-4347-ad06-29e9381d0526
Set id: 1b98a3dc-1999-4db1-86e4-b0ab7d9ce808
Version: 1
Effective Time: 20180712
 
Kroger