Label: COLD AND HOT- menthol cream
- NDC Code(s): 59240-003-01
- Packager: MAGVERZ INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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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, waterClose
Temporarily relieves minor pain associated with:
Temporarily relieves minor painClose
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.Close
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.Close
- Keep Out of Reach of Childrens
Keep out of reach of childrens.Close
- Productt Label
- INGREDIENTS AND APPEARANCE
COLD AND HOT
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59240-003 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 0.075 g in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF YELLOW WAX BENZYL ALCOHOL CAPSAICIN CETOSTEARYL ALCOHOL CETYL ALCOHOL CETYL ESTERS WAX CETYL PALMITATE CITRUS PARADISI FRUIT OIL EDETATE DISODIUM DISTEARYLDIMONIUM CHLORIDE EUCALYPTUS OIL GLYCERIN OLIVE OIL HYDROLYZED JOJOBA ESTERS (ACID FORM) SPEARMINT POLYSORBATE 60 POTASSIUM HYDROXIDE PROPANEDIOL SORBITAN OLIVATE PEG-80 SORBITAN PALMITATE STEARETH-2 STEARETH-21 STEARYL ALCOHOL WATER 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)