VANTELIN COOL PAIN RELIEVING GEL PATCH LARGE- menthol, methyl salicylate patch 
Kowa Health Care America, 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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VANTELIN COOL PAIN RELIEVING GEL PATCH LARGE

Drug Facts

Active ingredients 

Menthol 5%

Methyl salicylate 10%

Purpose 

Topical analgesic 

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with: 

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, ask a doctor before use.

Do not use

  • on wounds or damaged, broken or irritated skin
  • on very sensitive skin
  • with a heating pad or other heat source
  • if you are allergic to any ingredient in this product
  • in combination with other external analgesic products 

When using this product

  • do not use otherwise than as directed
  • do not get into eyes or on mucous membranes
  • do not bandage tightly or cover with any type of wrap

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • excessive irritation, burning, or discomfort of the skin develops
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days 

If pregnant or breastfeeding, ask a health professional before use. 

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away. 

Directions

Adults and children over 12 years: 

  • clean and dry affected area
  • remove film from patch
  • apply to affected area not more than 3 to 4 times daily
  • do not leave patch on skin for more than 8 hours
  • do not use for more than 7 consecutive days 

Children 12 years and younger: ask a doctor

Other information

  • avoid storing product in direct sunlight
  • protect product from excessive moisture
  • read all product information before using. Keep the carton for important information

Inactive ingredients

carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, methyl acrylate and 2-ethylhexyl acrylate copolymer, nonoxynol-30, partially neutralized polyacrylate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid 

Questions?

Visit Vantelin.com or call 1-888-655-9649

Kowa

VANTELIN 

COOL PAIN RELIEVING GEL PATCH LARGE

Menthol 5%

Methyl salicylate 10%

LOWER BACK

NECK & SHOULDER

Deep Penetrating, Medical Strength Relief 

Lasts up to 8 Hours*

*when used as directed 

5 Patches

3-15/16" x 7-7/8" (10 cm x 20 cm) each 

Cool Gel Patch Carton Large

VANTELIN COOL PAIN RELIEVING  GEL PATCH LARGE
menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71148-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5   in 100 
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10   in 100 
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CASTOR OIL (UNII: D5340Y2I9G)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TARTARIC ACID (UNII: W4888I119H)  
Product Characteristics
ColorwhiteScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71148-102-051 in 1 BOX03/09/201712/31/2018
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/09/201712/31/2018
Labeler - Kowa Health Care America, Inc. (078740352)

Revised: 4/2018
Document Id: ec7c637a-eef9-40ae-84c0-89ebb0a8dbc7
Set id: 51637a8f-e82f-49ec-b017-bee112176072
Version: 3
Effective Time: 20180423
 
Kowa Health Care America, Inc.