FDA Label for Assured Ice Cold Topical Analgesic
View Indications, Usage & Precautions
Assured Ice Cold Topical Analgesic Product Label
The following document was submitted to the FDA by the labeler of this product Greenbrier International, Inc.. 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.
Active Ingredient
Menthol 1.25%
Purpose
Topical Analgesic
Uses
for the temporary relief of minor aches and pains of muscles and joints
Warnings
For external use only. Avoid contact with eyes.
Ask a doctor before use if you have cough associated with
- smoking
- excessive phlegm
- asthma
- emphysema
- persistent or chronic cough
When Using This Product Do Not
- heat
- microwave
- add to hot water or any container where healing water may cause splattering and result in burns
- use in eyes or directly on mucous membranes
- take by mouth or place in nostrils
- apply to wounds or damaged skin
- bandage skin
Consult A Doctor And Discontinue Use
if condition worsens, persist for more than 1 week or tends to recur
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
- see important warnings under "When using this product"
- adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
- children under 2 years of age: consult a physician.
Other Information
store at 20 to 25 degreesC (68 to 77degrees F)
Inactive Ingredients
camphor, carbomer, ethyl alcohol, FDandC blue no.1, isopropyl alcohol, methylchloroisothiasolinone, methylisothiazolinone, sodium hydroxide, water.
Package Label.Principal Display Panel
Assured ICE COLD
Topical Analgesic Gel
Net wt 8oz (227g)
DISTRIBUTED BY:
GREENBRIER INTERNATIONAL, INC.
CHESAPEAKE, VA 23320
MADE IN CHINA
Assured Ice Cold Topical Analgesic Gel 8Oz (33992-7994-8)
* Please review the disclaimer below.
