COLD AND HOT PAIM RELIEVING CAREONE- menthol 16.00% liquid 
CareOne

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 16%.....................................................Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles
and joints associated with: • arthritis • simple backache • strains
• sprains • bruises


For external use only.
When using this product • use only as directed • do not
bandage tightly or use with a heating pad • avoid contact with
eyes and mucous membranes • do not apply to wounds or
damaged, broken or irritated skin • if you experience pain,
swelling, or blistering of the skin where an OTC topical muscle
and joint pain reliever was applied, stop using the product and
seek medical attention immediately. These products should not
cause pain or skin damage.
Stop use and ask doctor if • condition worsens • redness is
present • irritation develops • symptoms persist for more than 7
days or clear up and occur again within a few days
Flammable • keep away from fire or flame

Keep out of reach of children.

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

Directions


Adults and children over 12 years: • apply to affected area but
no more than 3 to 4 times daily • IF MEDICINE COMES IN
CONTACT WITH HANDS, WASH WITH SOAP AND WATER.
Children 12 years or younger: ask a doctor

Inactive ingredients

 Acrylates/C10-30 Alkyl
Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate,
Propylene Glycol, SD Alcohol 40 (30%), Triethanolamine, Water

image descriptionimage description

COLD AND HOT PAIM RELIEVING  CAREONE
menthol 16.00% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-777
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Capsaicin (UNII: S07O44R1ZM)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Propylene Glycol (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
TROLAMINE (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-777-031 in 1 CARTON07/14/2015
173 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/14/2015
Labeler - CareOne (809183973)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(41520-777) , label(41520-777)

Revised: 1/2018
Document Id: b186f2f0-a184-4e74-8b4f-917292ad055f
Set id: 40ad3ada-5f4f-42c4-9a9c-468c8d5e3de9
Version: 1
Effective Time: 20180109
 
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