NOPEN COOL- glycol salicylate, levomenthol patch 
JW HOLDINGS CORPORATION

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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NOPEN COOL

Active Ingredients (in each patch)

Glycol Salicylate 35mg

L-Menthol 35mg

Purpose

Topical Analgesic

Uses

Temporary relieves mild to moderate aches and pains of muscles and joints associated with:

■simple backache ■bruises ■sprains ■shoulder pains ■muscle pains ■arthritis

Warnings

For external use only

Do not use

■on the face or rashes ■wounds or damaged skin ■with a heating pad ■if you are allergic to salicylates

■when sweating (Such as from exercise or heat) ■on children under 12 years of age

Ask a doctor before use if

■ you have redness over the affected area ■ pregnant or breast feeding

When using this product

■ wash hands after applying or removing patch. ■ avoid contact with eyes or mucous membranes. ■ if eye contact occurs, rinse thoroughly with water. ■ do not bandage tightly

Stop use and ask a doctor if

■ rash, itching or skin irritation develops ■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days

Keep out of reach of children

Package not child-resistant. Dispose of the used patches after folding sticky ends together. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

■ clean and dry affected area before applying

■ peel off protective backing and apply sticky side to affected area and leave in place for up to 8 to 12 hours

■ remove used patch from skin before applying a new patch

Other Information

■ store at 20℃ to 25℃ (68℉ to 77℉)

■ avoid storing product in direct sunlight

■ protect product from excessive moisture

■ some individuals may not experience pain relief until several hours after applying the patch

Inactive ingredients

Acryl Adhesive, Nonwoven Polyester Fabric, Paper Release Liner, Rubber Adhesive, Vanillyl Butyl Ether

Questions or comments?

Call 1-562-281-5888 Monday-Friday 9AM-4PM ET

Distributed by: Jemian USA Inc

Principal Display Panel-5 Patches

JW Pharmaceutical

NOPEN

Cool

Neutral sensation type Glycol Salicylate/ L-Menthol

5 Patches

2.7 in x 3.9 in (7 cm x 10 cm)

NOPEN Cool Patch

NOPEN COOL 
glycol salicylate, levomenthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69365-006
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCOL SALICYLATE (UNII: 3I1VBB7AXH) (GLYCOL SALICYLATE - UNII:3I1VBB7AXH) GLYCOL SALICYLATE35 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM35 mg
Inactive Ingredients
Ingredient NameStrength
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.70-1.00) (UNII: 645M2T7FHZ)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
Product Characteristics
Color    Score    
ShapeRECTANGLE (2.7 in x 3.9 in (7 cm x 10 cm)) Size
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69365-006-015 in 1 POUCH; Type 0: Not a Combination Product08/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/17/2018
Labeler - JW HOLDINGS CORPORATION (631094492)
Registrant - JW HOLDINGS CORPORATION (631094492)

Revised: 8/2018
Document Id: 73da2dad-c93c-f85f-e053-2991aa0a176f
Set id: 67f7944d-4048-2305-e053-2991aa0af616
Version: 2
Effective Time: 20180820
 
JW HOLDINGS CORPORATION