COLD AND HOT- menthol spray

Cold and Hot by

Drug Labeling and Warnings

Cold and Hot by is a Otc medication manufactured, distributed, or labeled by MAGVERZ INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Acitves

Menthol 16 %

Inactives

Glycerin.

Propylene Glycol

SD Alchohol 40-2(55%)

Water (283-016)

Uses

Temporarily relieves minor pain associated with:

arthritissimple

backachemuscle

strainss

prains

bruise

scramps

Indication

Temporarily relieves minor pain

Directions

Spray affected are with desired amount of product

Product will dry quickly on its own and doest not to be rubbed in

Repeat as necessary but not more than 3-4 times dilay

Warnings

For External use only

When using this product

 Use only as directed

 Do not bandage tightly or with heating pad

 Avoid contact with eyes and mucous membranes

 Do not apply to wounds or damagged, broken or irritated skin

 Do not spray on face

 Avoid inhaling spray mist and fumes

Stop use and ask docotor if;

Condition Worsesns

Redness is presnt for more than 7 days

Irritation developes

Symptomps persist for mor than 7 dyas or clear up and occur again within a few days.

Flamalble
Do not use near heat or flame or while smoking.

Avod long term  storage  above 104oF (400C)

Do not puncture of or incinerate.Congents under pressure.

Do not store at temreture above 120oF (490C)

If pregnant or breast feeding

 Ask health professionals before use.

If sollowed get medical help or contact poison control center right away.

Keep Out of Reach of Childrens

Keep out of reach of childrens.

Productt Label

Product Label

INGREDIENTS AND APPEARANCE

COLD AND HOT 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59240-002
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
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
ZINC STEARATE (UNII: H92E6QA4FV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59240-002-10	150 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/18/2013

Labeler - MAGVERZ INC (078712269)

Registrant - MAGVERZ INC (078712269)