Label: COLD/HOT MEDICATED PATCHES- medicated patches patch
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Contains inactivated NDC Code(s)
NDC Code(s): 67777-145-10, 67777-145-20, 67777-145-30 - Packager: Dynarex Corporation
- Category: HUMAN OTC DRUG LABEL
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 November 7, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
Do not use
on wounds or damaged skin, with a heating pad, if you are allergic to any ingredients of this product
When using this product
use only as directed, avoid contact with the eyes, mucous membranes or rashes
- Directions
- Other information
- Inactive ingredients
- Label NDC 67777-145-10
- Label NDC 67777-145-20
- Label NDC 67777-145-30
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INGREDIENTS AND APPEARANCE
COLD/HOT MEDICATED PATCHES
medicated patches patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-145 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 100 mg in 5 mg Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TARTARIC ACID (UNII: W4888I119H) GLYCERIN (UNII: PDC6A3C0OX) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) CASTOR OIL (UNII: D5340Y2I9G) KAOLIN (UNII: 24H4NWX5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-145-10 180 in 1 CASE 08/15/2018 1 5 in 1 BOX 1 5 mg in 1 PATCH; Type 0: Not a Combination Product 2 NDC:67777-145-20 180 in 1 CASE 08/15/2018 2 5 in 1 BOX 2 5 mg in 1 PATCH; Type 0: Not a Combination Product 3 NDC:67777-145-30 108 in 1 CASE 08/15/2018 3 3 in 1 BOX 3 5 mg in 1 PATCH; 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 08/15/2018 Labeler - Dynarex Corporation (008124539)