COLD THERAPY PAIN RELIEF MEDICATED  GNP- menthol spray 
Amerisource Bergen

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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Cold Therapy Pain Relief Medicated Spray [GNP]

Active ingredient                                   Purpose

Menthol 10.5% ....................... . ........... Topical Analgesic

Uses

Temporary relief from minor aches and pains of muscles and joints associated with arthrttis, simple backache, strains and sprains

Wamings
For external use only.

Flammable: Do not use while smo~ng 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 atter use with cool water • do not use with heating pad or device
Stop use and ask a doctor if • condition worsens, or tt symptoms persist for more than 7 days, or clear up and reoccur again within a few days.

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, EchinaceaAngustifolia Extract,
llex Paraguariensis Leaf Extract, lsopropyl Myristate, Juniperus
Communis Fruit Extract, Water

Questions?

 888-793-8450

image description

COLD THERAPY PAIN RELIEF MEDICATED   GNP
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-657
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 WHOLE (UNII: VB06AV5US8)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
JUNIPER BERRY (UNII: O84B5194RL)  
WATER BUFFALO (UNII: 0A4PW6CRAI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-657-2185 g in 1 CAN; Type 0: Not a Combination Product01/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/12/2021
Labeler - Amerisource Bergen (007914906)
Registrant - Inspec Solutions LLC (081030372)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC081030372manufacture(46122-657)

Revised: 1/2021
Document Id: b8b9a3cd-c4ee-dfeb-e053-2a95a90aa719
Set id: 1c1e6ca9-ef43-4e19-88a1-704963250426
Version: 2
Effective Time: 20210112
 
Amerisource Bergen