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 Type HUMAN OTC DRUG Item Code (Source) NDC:20890-0020
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Camphor (SYNTHETIC) (UNII: 5TJD82A1ET)  
Nonoxynol-9 (UNII: 48Q180SH9T)  
Isopropyl Alcohol (UNII: ND2M416302)  
Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
Sodium Hydroxide (UNII: 55X04QC32I)  
FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
Methylisothiazolinone (UNII: 229D0E1QFA)  
Product Characteristics
Color BLUE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:20890-0020-1 226 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 12/01/2010
Labeler - Abaco Partners LLC DBA Surefil (964809417)
Establishment
Name Address ID/FEI Business Operations
Anicare Pharmaceutical Pvt. 916837425 MANUFACTURE

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