LANDER POLAR ICE- menthol gel 
Abaco Partners LLC DBA Surefil

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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LANDER®
POLAR ICE
TOPICAL ANALGESIC GEL

Drug Facts

Active Ingredients

Menthol, 2.0%

Purpose

Topical analgesic

Uses

Temporarily relieves:

-
Minor muscle aches and pains

Warnings

For external use only; avoid contact with eyes

When using this product, do not;

-
heat
-
microwave
-
add to hot water or any container where heating 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 products"

-
not for use on children under 2 years of age
-
adults & children 2 years & older: apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.

Inactive Ingredients

FD&C Blue #1, Camphor, Carbomer, Isopropyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Nonoxynol - 9, Propylene Glycol, Sodium Hydroxide, Water.

Polar Ice® is a registered trademark of Grand Brands LLC, Grand
Rapids, MI 49512 USA

UPC: 8-14344-0-1123-9

PRINCIPAL DISPLAY PANEL - 226g Container

LANDER®
America's Health & Beauty Care Company

POLAR
ICE
TOPICAL ANALGESIC GEL

NET WT. 8 OZ (226g)

Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 226g Container
LANDER  POLAR ICE
menthol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:20890-0020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Propylene Glycol 
Camphor (SYNTHETIC) 
Nonoxynol-9 
Isopropyl Alcohol 
Carbomer Homopolymer Type C 
Sodium Hydroxide 
FD&C Blue NO. 1 
Methylchloroisothiazolinone 
Methylisothiazolinone 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20890-0020-1226 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35612/01/2010
Labeler - Abaco Partners LLC DBA Surefil (964809417)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceutical Pvt.916837425MANUFACTURE

Revised: 10/2010
Document Id: 6cc082b1-ae18-49ed-a51b-d1c5c28792ee
Set id: 35abbfe2-39a3-4f24-b23e-84d8614e07e7
Version: 1
Effective Time: 20101018
 
Abaco Partners LLC DBA Surefil