DT ICE COLD ANALGESIC- menthol gel 
Volume Distributors, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DT Ice Cold Analgesic Gel

DRUG FACTS

Active ingredients                        Purpose

Menthol (1%)................................Topical Analgesic

Purpose
topical analgesic

Uses-

temporarily relieves:minor muscle aches and pains

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, persists 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

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 Ingredients: Camphor, Carbomer, FDandC Blue No1, Isopropyl Alcohol, methylchloroisothiazolinone, methylisothiazolinone, Sodium hydroxide, water.

DT ICE COLD
ANALGSIC GEL

Distributed by:
DT products
Vernon,CA 90058
MADE IN CHINA

Ice Cold Analgesic

DT ICE COLD ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50523-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50523-000-08227 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/22/2010
Labeler - Volume Distributors, Inc. (002029544)

Revised: 8/2015
Document Id: 9686d3fc-f7ab-4ba1-9c2b-304caeb77e6d
Set id: 40a23724-6449-4ee7-99f9-b57b54579f23
Version: 5
Effective Time: 20150803
 
Volume Distributors, Inc.