COLD AND HOT- menthol spray 
MAGVERZ INC

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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Cold and Hot Spray

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

image Product Label

COLD AND HOT 
menthol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59240-002
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 7/2013
Document Id: fa8835a8-5f7b-487f-bfc6-6d2740f1e412
Set id: 13223ed1-8101-4ba8-aeab-c9ed329946d8
Version: 1
Effective Time: 20130713
 
MAGVERZ INC