VANTELIN COOL PAIN RELIEVING GEL

Drug Labeling and Warnings

Drug Details [pdf]

VANTELIN COOL PAIN RELIEVING- camphor, menthol, methyl salicylate gel 
Ei LLC

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

Active ingredients

Camphor 4%

Menthol 12%

Methyl salicylate 30%

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.

​Flammable:​ Keep away from fire or flame

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
• 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 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, glycerin, hydroxypropyl cellulose, purified water, SD alcohol 40B, sodium acetyl hyaluronate, sodium pyrrolidone carboxylate, urea

Questions?

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

Kowa

VANTELIN

COOL PAIN RELIEVING GEL

Camphor 4%, Menthol 12%, Methyl salicylate 30%

NECK & SHOULDER

LOWER BACK

No-mess dome-head applicator

Net Wt. 2.1 oz (60g)

VANTELIN COOL PAIN RELIEVING 
camphor, menthol, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52512-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	2.4 g  in 60 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.2 g  in 60 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	18 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
UREA (UNII: 8W8T17847W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52512-106-21	1 in 1 CARTON	05/24/2017
1		60 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/24/2017	06/30/2019

Labeler - Ei LLC (105803274)

Revised: 5/2018

Document Id: d3e992e9-3276-4316-b28d-6ee99fdca2e4

34390-5

Set id: 9a797a77-ab84-4272-b556-a302354b452b

Version: 3

Effective Time: 20180518