COLD AND HOT CVS- menthol 7.6% mehyl salicylate 29.0% spray 
CVS

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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Active ingredients

Menthol 7.60%
Methyl Salicylate 29.00%


Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and
joints associated with: • arthritis • simple backache • muscle strains
• bruises • sprains

Warnings

For external use only.

Flammable • keep away from fire or flame • do not use while smoking or
near heat or flame • avoid long term storage above 104˚F. • do not puncture
or incinerate. Contents under pressure. • do not store at temperatures
above 120˚F.
When using this product • avoid contact with eyes and mucous
membranes • do not apply to wounds or damaged skin • do not bandage
tightly • use only as directed
Stop use and ask doctor if • condition worsens • symptoms persist for
more than 7 days or clear up and occur again within a few days • needed for
longer than 1 week
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get help or contact a Poison Control Center right away.

Directions

 • shake well • adults and children 2 years of age and older:
spray product on affected area, not more than 3 to 4 times
daily. • children under 2 years of age: consult a doctor

Inactive ingredients

Alcohol Denat.
Arnica Montana Flower Extract
Boswellia Serrata Gum Extract
Dimethyl Sulfone
Eucalyptus Globulus Leaf Oil
Ilex Paraguariensis Leaf Extract
Mentha Piperita (Peppermint) Oil
Olea Europaea (Olive) Fruit Oil
Propylene Glycol
Water

image description

COLD AND HOT  CVS
menthol 7.6% mehyl salicylate 29.0% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-269
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE29.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-269-04113 g in 1 CAN; Type 0: Not a Combination Product11/13/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/13/2014
Labeler - CVS (062312574)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(59779-269)

Revised: 5/2018
Document Id: 5f0d9ce2-a850-4b91-a9e2-5747dd49c8c6
Set id: 4d499e0c-cb59-4af4-aabb-58c5318f1dee
Version: 4
Effective Time: 20180510
 
CVS