FDA Label for Cvs Hot And Cold Balm
View Indications, Usage & Precautions
Cvs Hot And Cold Balm Product Label
The following document was submitted to the FDA by the labeler of this product Cvs. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Menthol 7.6%
Methyl Salicylate 29%
Otc - Purpose
Topical analgesic
Indications & Usage
temporarily relieves minor pain associated with
arthritis
simple backache
muscle strains
sprains
bruises
cramps
Warnings
For External use only
Allergy alert
If prone to allergic reaction from aspirin or salicylates, consult a doctor before use
Otc - When Using
When using the product
Use only as directed. Read and follow all directions and warnings on this label
Avoid 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 tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
do not use at the same time as other topical analgesics
a transient burning sensation may occur upon application but generally disappears in seven 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 a doctor if
condition worsens
redness is present
irritation develops
symptoms persist for more than 7 days or clear up and occur again within a few days
you experience signs injury, such as pain, swelling, or blistering where the product was applied
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Dosage & Administration
Directions adults and children over 12 years:
apply a thin layer to affected area
massage into painful area until thoroughly absorbed into skin
repeat as necessary, but more than 4 times daily
AFTER APPLYING, WASH HANDS WITH SOAP AND WATER children 12 years or younger: ask a doctor
Inactive Ingredient
Paraffin, white petrolatum
Package Label.Principal Display Panel
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