Active Ingredients
Camphor 3.0%
Menthol 1.25%
Assured Ice Cold Topical Analgesic
FDA Label NDC 33992-7993
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc. for the product Assured Ice Cold Topical Analgesic (NDC 33992-7993). 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, when using this product do not, consult a doctor and discontinue use, keep out of reach of children., directions, 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
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
carbomer, 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
Ice Cold Analgesic Gel (Icecold)
* Please review the disclaimer below.
