Acitves
Menthol 7.5%
Cold And Hot
FDA Label NDC 59240-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Magverz Inc for the product Cold And Hot (NDC 59240-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding acitves, inactives, uses, indication, directions, warnings, keep out of reach of childrens, productt label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 (Hot Ncold Nat)
* Please review the disclaimer below.
