Label: MANAMED LIDOCAINE 4% PAIN RELIEVING GEL PATCH- lidocaine patch
- NDC Code(s): 82728-001-01
- Packager: Manamed, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 20, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
- 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 is product
- Use only as direacted
- Read and follow all direactions and warnings on this carton
- Do not allow contact with 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 the use
- Do not microwave
- Dispose of used patch in the manner that always keeps product away from childen 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.
Stop use and consult a doctor if
- Condition worsens
- Redness is present
- Irritation develops
- Symtoms persists 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.
If pregnant or breastfeading, ask health professional before use.
Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Product label
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INGREDIENTS AND APPEARANCE
MANAMED LIDOCAINE 4% PAIN RELIEVING GEL PATCH
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82728-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) KAOLIN (UNII: 24H4NWX5CO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82728-001-01 6 in 1 BOX 06/22/2022 1 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 Drug M017 06/22/2022 Labeler - Manamed, Inc. (084042331)