Label: NOPEN COOL- glycol salicylate, levomenthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 69365-006-01 - Packager: JW HOLDINGS CORPORATION
- 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.
Drug Label Information
Updated August 20, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients (in each patch)
- Purpose
- Uses
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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
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
- Directions
- Other Information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel-5 Patches
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INGREDIENTS AND APPEARANCE
NOPEN COOL
glycol salicylate, levomenthol patchProduct 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)