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1454 Lidocaine Pain Relief Gel-Patch NDC: 67777-009-40

1454 Lidocaine Pain Relief Gel-Patch NDC: 67777-009-40

Drug Labeling and Warnings

Drug Details

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LIDOCAINE PAIN RELIEF GEL PATCH- lidocaine pain relief patch 
Dynarex

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.

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1454 Lidocaine Pain Relief Gel-Patch NDC: 67777-009-40

Active Ingredients

Lidocaine 4%

Puropose

Topical anesthetic

Use

For temporary relief of pain

Warnings

For external use only

Do not use

  • more than 1 patch at a time
  • 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
  • do not bandage tightly

Stop use and ask a doctor if

  • localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

if pregnant or breast feeding

ask a health professional before use

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove film from patch and apply to the skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • patch should not be applied longer than an 8 hour period

Children under 12 years of age: consult a doctor

Other Information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive Ingredients

Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid (8000MW), Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate (8000MW), Tartaric Acid, Titanium Dioxide, Tween 80, Water

Questions?

1-888-DYNAREX

Label

1454 Lidocaine Patchs PDP

LIDOCAINE PAIN RELIEF GEL PATCH 
lidocaine pain relief patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67777-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONE (UNII: FZ989GH94E)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TARTARIC ACID (UNII: W4888I119H)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67777-009-4060 in 1 CASE08/27/2019
15 in 1 BOX
140 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/27/2019
Labeler - Dynarex (008124539)
Registrant - Dynarex (008124539)

Revised: 10/2019
 
Dynarex


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