Label: COLD AND HOT- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59240-003-01 - Packager: MAGVERZ INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 16, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Acitves
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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
- Indication
- Directions
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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
- Productt Label
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INGREDIENTS AND APPEARANCE
COLD AND HOT
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59240-003 Route of Administration TOPICAL 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)