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

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 GEL

VANTELIN COOL PAIN RELIEVING
camphor, menthol, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71148-106
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71148-106-21	1 in 1 CARTON	05/24/2017
1		60 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

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

Labeler - Kowa Health Care America, Inc. (078740352)

Revised: 10/2018

Document Id: 78ef8760-e4a7-57d8-e053-2991aa0af7a5

Set id: 4eb1da45-a7a4-4aba-961a-35db43a6fcf6

Version: 2

Effective Time: 20181023

Kowa Health Care America, Inc.