Label: LIDOCAINE WITH MENTHOL PATCH PAIN RELEIF- lidocaine 4% and menthol 1% patch
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Contains inactivated NDC Code(s)
NDC Code(s): 55629-061-01, 55629-061-03 - Packager: ONE2ZEE LIMITED LIABILITY COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Active ingredient
Lidocaine 4%
Menthol 1%
Uses
Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.
Do not Use
- more than 1 patch on your body at a time or on cut, irritated or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
When Using This Product
- use only as directed. Read and follow all directions and warnings on this label.
- do not allow contact with the eyes
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- do not use at the same time as other topical analgesics
- dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Stop Use and Ask a Doctor if
- condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or clear up and occur again within a few days
- you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Keep Out of Reach of Children and Pets
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Adults and children over 12 years:
- clean and dry affected area
- remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
- carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
- once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
- use 1 patch for up to 12 hours
children 12 years or younger: ask a doctor
- Package / Principle Label
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INGREDIENTS AND APPEARANCE
LIDOCAINE WITH MENTHOL PATCH PAIN RELEIF
lidocaine 4% and menthol 1% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55629-061 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg Inactive Ingredients Ingredient Name Strength KAOLIN (UNII: 24H4NWX5CO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55629-061-03 20 in 1 BOX 01/26/2021 1 NDC:55629-061-01 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 01/26/2021 Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111) Registrant - NE2ZEE LIMITED LIABILITY COMPANY (078656111) Establishment Name Address ID/FEI Business Operations DR SABHARWAL'S WOUND CARE 862184668 manufacture(55629-061) , analysis(55629-061)
