COOL AND HEAT- menthol 16% spray 
Top Care

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.

----------

Drug Facts

Active ingredient                          Purpose

Menthol 16%                                 Topical analgesic

Uses

• temporarily relief of pain and itching associated with:

• arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

Warnings
For external use only

Flammable

• do not use while smoking or near heat or flame
• avoid long term storage above 104​oF
• do not puncture or incinerate. Contents under pressure
• do not store at temperature above 120​oF

When using this product

• avoid contact with eyes and mucous membranes
• do not apply to wounds or damages skin
• do not bandage tightly
• use only as directed

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
•needed for longer than 1 week

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

If pregnant or breast-feeding, ask a health professional before use.

Directions

• shake well
• adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily
• children under 12 years of age: consult a doctor

Inactive ingredients

Glycerin, Propylene Glycol, SD Alcohol 40, Water

image description

COOL AND HEAT 
menthol 16% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Alcohol (UNII: 3K9958V90M)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-730-04113 g in 1 CAN; Type 0: Not a Combination Product01/22/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/22/2013
Labeler - Top Care (006935977)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(36800-730) , label(36800-730)

Revised: 7/2018
Document Id: 4d60a8f7-64fb-41ed-9818-514942a94852
Set id: 5b13d4a3-83da-4938-8bbe-ffda8498c116
Version: 1
Effective Time: 20180718
 
Top Care