COLD AND HOT PAIM RELIEVING CAREONE- menthol 16.00% liquid

Cold and Hot paim relieving by

Drug Labeling and Warnings

Cold and Hot paim relieving by is a Otc medication manufactured, distributed, or labeled by CareOne, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                               Purpose

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

PURPOSE

Uses

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

WARNINGS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD AND HOT PAIM RELIEVING  CAREONE
menthol 16.00% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-777
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-777-03	1 in 1 CARTON	07/14/2015
1		73 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/14/2015

Labeler - CareOne (809183973)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(41520-777) , label(41520-777)