Otc - Active Ingredient
DRUG FACTS
Active ingredients Purpose
Menthol (1%)................................Topical Analgesic
Dt Ice Cold Analgesic
FDA Label NDC 50523-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Volume Distributors, Inc. for the product Dt Ice Cold Analgesic (NDC 50523-000). 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 - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
topical analgesic
Indications & Usage
Uses-
temporarily relieves:minor muscle aches and pains
Warnings
Warnings
For external use only; avoid contact with eyes.
Otc - Ask Doctor
Ask a doctor before use if you have cough associated with
smoking
excessive phlegm
asthma
emphysema
persistent or chronic cough
Otc - When Using
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.
Otc - Stop Use
Consult a doctor and discontinue use;
if condition worsens, persists for more than 1 week or tends to recur.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately
Dosage & Administration
Directions
For the temporary relief of minor muscle aches and pains.
See important warnings under "When Using This Product"
not for use on children under 2 years of age
adults and children 2 y ears and older: apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.
Inactive Ingredient
Inactive Ingredients: Camphor, Carbomer, FDandC Blue No1, Isopropyl Alcohol, methylchloroisothiazolinone, methylisothiazolinone, Sodium hydroxide, water.
Package Label.Principal Display Panel
DT ICE COLD
ANALGSIC GEL
Distributed by:
DT products
Vernon,CA 90058
MADE IN CHINA
Ice Cold Analgesic (Dticecold)
* Please review the disclaimer below.
