Label: NOPEN COOL- glycol salicylate, levomenthol patch
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated August 20, 2018
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- Active Ingredients (in each patch)
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
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
- Other Information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel-5 Patches
INGREDIENTS AND APPEARANCE
glycol salicylate, levomenthol patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69365-006 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOL SALICYLATE (UNII: 3I1VBB7AXH) (GLYCOL SALICYLATE - UNII:3I1VBB7AXH) GLYCOL SALICYLATE 35 mg MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 35 mg Inactive Ingredients Ingredient Name Strength 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 Shape RECTANGLE (2.7 in x 3.9 in (7 cm x 10 cm)) Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69365-006-01 5 in 1 POUCH; Type 0: Not a Combination Product 08/17/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/17/2018 Labeler - JW HOLDINGS CORPORATION (631094492) Registrant - JW HOLDINGS CORPORATION (631094492)