VANTELIN ODORLESS PAIN RELIEVING- trolamine salicylate cream 
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 ODORLESS PAIN RELIEVING CREAM

Active ingredient

Trolamine salicylate 10%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches & pains of muscles & 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 bandage tightly or cover with any type of wrap
  • avoid getting into the eyes or on mucous membranes

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

​If pregnant or breast-feeding,​ 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:

   • apply generously to affected area

   • massage into painful area until thoroughly absorbed

   • repeat as necessary, but no more than 3 to 4 times daily

  • Children 12 years and younger: ask a doctor

Other information

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

Inactive ingredients

arnica montana flower extract, cetyl alcohol, edetate disodium, emulsifying wax, glycerin, hyaluronate sodium, methylparaben, mineral oil, monobasic potassium phosphate, polysorbate 80, potassium hydroxide, propylparaben, purified water, sodium pyrrolidone carboxylate, stearic acid, urea, vitamin E

Questions?

Visit Vantelin.com or ​1-888-655-9649

Kowa

VANTELIN

ODORLESS PAIN RELIEVING CREAM

Trolamine salicylate 10%

NECK & SHOULDER

LOWER BACK

No-mess dome-head applicator

Net Wt. 2.1 oz (60 g)

Vantelin Cream

VANTELIN ODORLESS PAIN RELIEVING 
trolamine salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71148-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
UREA (UNII: 8W8T17847W)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71148-107-211 in 1 CARTON05/24/2017
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/24/201706/30/2019
Labeler - Kowa Health Care America, Inc. (078740352)

Revised: 5/2018
 
Kowa Health Care America, Inc.