Label: COLD AND HEAT LIDOCAINE PATCH PLUS MENTHOL- lidocaine, menthol patch
- NDC Code(s): 0363-0914-05
- Packager: Walgreen Company
- 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 January 11, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- USES
-
WARNINGS
- For External use only. Use only as directed.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
■ More than one patch on your body at a time
■ On cut, irritated or swollen skin
■ On puncture wounds
■ For more than one week without consulting a doctor
■ If you are allergic to any active or inactive ingredients
■ If pouch is damaged or opened.
WHEN USING:
■ Use only as directed
■ Read and follow all directions and warnings on this carton
■ Do not allow contact with the eyes
■ Do not use at the same time as other topical analgesics
■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ Do not microwave
■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain
the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. - DIRECTIONS Adults and children 12 years of age and over:
- INACTIVE INGREDIENTS
- STORAGE AND HANDLING
- Lidocaine + Menthol Patch
-
INGREDIENTS AND APPEARANCE
COLD AND HEAT LIDOCAINE PATCH PLUS MENTHOL
lidocaine, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0914 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 g in 100 g Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461) PROPYLPARABEN (UNII: Z8IX2SC1OH) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0914-05 5 in 1 POUCH 07/01/2018 1 8 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/01/2018 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co.,Ltd. 529128763 manufacture(0363-0914)