LIdoReal-30 4% Topical Patch

LidoReal-30 4% Topical Patch by

Drug Labeling and Warnings

LidoReal-30 4% Topical Patch by is a Otc medication manufactured, distributed, or labeled by ForReal Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIDOREAL-30 4% TOPICAL PATCH- lidocaine 4% patch 
ForReal Pharmaceuticals

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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LIdoReal-30 4% Topical Patch

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

For the 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 occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • 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 or over:

  • Clean and dry the affected area
  • Open pouch and remove one patch
  • Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
  • Reseal pouch containing unused patches after each use
  • Remove patch from the skin after at most 8-hour application

Children under 12 years of age:

  • Consult a doctor

Other Information

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

Other Ingredients

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Questions or comments? 877-367-3250

LidoReal-30 4% Topical Patch

NDC: 81877-504-30

Qty: 30 Flex Patches

(5 per resealable pouch) x 6

Manufactured for:

ForReal Pharmaceuticals

Royal Oak, MI 48067

Label

LIDOREAL-30 4% TOPICAL PATCH 
lidocaine 4% patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81877-504(NDC: 70512-014)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
FLAX SEED (UNII: 4110YT348C)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ACRYLIC ACID (UNII: J94PBK7X8S)  
Product Characteristics
Color    Score    
ShapeRECTANGLE (White Flexible Patch) Size
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81877-504-306 in 1 BOX05/24/202109/08/2022
15 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/24/202109/08/2022
Labeler - ForReal Pharmaceuticals (118029197)

Revised: 9/2022
Document Id: 57a77d12-4de1-4fb3-9779-8979ff4d9712
Set id: c964f41f-eae5-2dbb-e053-2995a90adfe9
Version: 5
Effective Time: 20220908