MERICAINE- lidocaine gel 
Merit Pharmaceutical

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Mericaine ​TM​ - LIDOCAINE 4% Topical Gel - lidocaine gel

Merit Pharmaceuticals

Drug Facts
Lidocaine 4% Gel

Active Ingredient

Lidocaine 4% w/w

Purpose

Topical Anesthetic

Uses

Temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites

Warnings

For external use only.  Not for ophthalmic use.

Do not use:

  • in or near the eyes
  • in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children

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

Directions

  • Adults and children 2 years and older:  Apply externally to the affected area up to 3 to 4 times a day.
  • Children under 2 years of age:  Consult a doctor.

Inactive Ingredients

alcohol, benzyl alcohol, carbomer, citric acid, ethoxydiglycol, propylene glycol, and purified water.

Other Information

  • May be applied under occlusive dressing.
  • Store at 25 ​0​C (77 ​0​F); excursions permitted to 15-30 ​0​C (59-86 ​0​F) [See USP Controlled Room Temperature].

image description

MERICAINE 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30727-810
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30727-810-301 in 1 BOX07/01/2016
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/201507/02/2024
Labeler - Merit Pharmaceutical (093370369)
Registrant - Merit Pharmaceutical (093370369)
Establishment
NameAddressID/FEIBusiness Operations
Biozone Laboratories, Inc.962455320manufacture(30727-810) , analysis(30727-810) , pack(30727-810) , label(30727-810)

Revised: 7/2024
Document Id: 1c322409-5237-f071-e063-6294a90a3e79
Set id: 59a0ab33-8c41-4765-bfbd-fb92046440ae
Version: 7
Effective Time: 20240701
 
Merit Pharmaceutical