Active Ingredients
Menthol 7.60%
Methyl Salicylate 29.00%
Cold And Hot
FDA Label NDC 64048-3334
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Product Quest Mfg, Llc for the product Cold And Hot (NDC 64048-3334). 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 active ingredients, purpose, uses, warnings, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and
joints associated with: • arthritis • simple backache • muscle strains
• bruises • sprains
Warnings
For external use only.
Flammable • keep away from fire or flame • do not use while smoking or
near heat or flame • avoid long term storage above 104˚F. • do not puncture
or incinerate. Contents under pressure. • do not store at temperatures
above 120˚F.
When using this product • avoid contact with eyes and mucous
membranes • do not apply to wounds or damaged skin • do not bandage
tightly • use only as directed
Stop use and ask doctor if • condition worsens • symptoms persist for
more than 7 days or clear up and occur again within a few days • needed for
longer than 1 week
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get help or contact a Poison Control Center right away.
Directions
• shake well • adults and children 2 years of age and older:
spray product on affected area, not more than 3 to 4 times
daily. • children under 2 years of age: consult a doctor
Inactive Ingredients
Alcohol Denat.
Arnica Montana Flower Extract
Boswellia Serrata Gum Extract
Dimethyl Sulfone
Eucalyptus Globulus Leaf Oil
Ilex Paraguariensis Leaf Extract
Mentha Piperita (Peppermint) Oil
Olea Europaea (Olive) Fruit Oil
Propylene Glycol
Water
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