Otc - Active Ingredient
Menthol 16%
Cvs Cold And Hot Spray
FDA Label NDC 51316-899
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Cvs Cold And Hot (NDC 51316-899). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Indications & Usage
Temporarily alleviates minor aches and pains of muscles and joints associated with
Arthritis
Simple Backache
Strains
Bruises
Cramps
Warnings
For external use only
Flammable:
Do not use while smoking or near heat or flames. Avoid longterm storage above 104°F. Do not punctuate or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
Otc - When Using
When using this product use only as directed
Read and follow all directions and warnings on this label
Do not allow contact with eyes and mucous membranes
Rare cases of serious burns have been reported with products of this type
Do not apply to wounds or damaged, broken or irritated skin
Do not bandage or apply local heat (such as heating pads) or medicated patch to the area of use
A transient burning sensation may occur upon application but generally disappears in several days
If severe burning sensations occurs, discontinue use immediately
Do not expose the area treated with product to heat or direct sunlight
Avoid applying into skin folds
Otc - Stop Use
Stop use and ask doctor if condition worsens, redness is present, irritation develops or symptoms persist for more than 7 days or clear up and occur again within few days. Do not use for longer than 1 week.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions:
Shake well - adults and children 12 years of age and older: spray product on affected area, not more than 3 to 4 times daily.
- children under 12 years of age: consult a doctor.
Inactive Ingredient
Glycerin, Isobutane, Propylene Glycol, SD Alcohol 40B (29%), Water
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