COLD AND HOT- menthol cream 
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 Cream

Acitves

Menthol 7.5%

Inactives

aloe barbadensis leaf juice, beeswax, benzyl alcohol, capsaicin, cetearyl alcohol, cetyl alcohol, cetyl esters, cetyl palmitate, citrus paradise (grapefruit) peel oil, di-PEG-2 soyamine IPDI, disodium LPDL, distearyldimonium chloride, eucalyptus globules leaf oil, glycerin, hydrogenated olive oil, jojoba esters, melaleuca alternifolia (tea tree) leaf oil, menthe viridis (spearmint) leaf oil, olea europaea (olive) fruit oil, olea europaea (olive) oil unsaponifiables, polysorbate 60, potassium hydroxide, propanediol, sorbitan olivate, sorbitan palmitate, steareth-2, steareth-21, stearyl alcohol, water

Uses

Temporarily relieves minor pain associated with:

arthritis

backache  

bodyaches

muscle pains

leg cramps

bursitis

Indication

Temporarily relieves minor pain

Directions

Adults and children over 1 years:apply generously to affected areamassage into painful area until thoroughly absorbed into skinrepeat as necessary, but no more than  4 times daily.

Children 12 years or younger: ask a doctor.

Close cap tighlty after use.

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 expose the area treated with product to heat or direct sunlight.

Stop use and ask docotor if;


Condition Worsesns, Symptomps persist for mor than 7 days or clear up and occur again within a few days, Irritation developes.

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 cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59240-003
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.075 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAPSAICIN (UNII: S07O44R1ZM)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
CITRUS PARADISI FRUIT OIL (UNII: 6A7N43E0OJ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
SPEARMINT (UNII: J7I2T6IV1N)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPANEDIOL (UNII: 5965N8W85T)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
PEG-80 SORBITAN PALMITATE (UNII: 4NR71FN0IA)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59240-003-01 25 g in 1 TUBE
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: 23f2cb9b-3189-4389-a0b0-bfeb7c2ce53a
Set id: df791fdb-5984-43b0-b04c-2625ee6e5c0c
Version: 1
Effective Time: 20130716
 
MAGVERZ INC