COOL AND HEAT- menthol 16% spray

Cool and Heat by

Drug Labeling and Warnings

Cool and Heat by is a Otc medication manufactured, distributed, or labeled by Top Care, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                          Purpose

Menthol 16%                                 Topical analgesic

PURPOSE

Uses

 temporarily relief of pain and itching associated with:

arthritis simple backache muscle strains bruises cramps muscle sprains

WarningsFor 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOL AND HEAT 
menthol 16% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-730
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 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Alcohol (UNII: 3K9958V90M)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-730-04	113 g in 1 CAN; Type 0: Not a Combination Product	01/22/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/22/2013

Labeler - Top Care (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-730) , label(36800-730)