Lidocaine

Drug Labeling and Warnings

Drug Details [pdf]

LIDOCAINE- lidocaine cream 
County Line Pharamceuticals

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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Lidocaine

Drug Facts

Active ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

Helps relieve pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Warnings

For external use only.

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

Other information

  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive ingredients

benzyl alcohol, carbomer, lecithin, propylene glycol, purified water, vitamin E acetate.

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

NDC: 43199-054-30

NET WT. 30 grams

Lidocaine 5%
Anorectal Cream

county line pharmaceuticals, llc

Principal Display Panel - 30 g Tube Carton
LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43199-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Benzyl Alcohol (UNII: LKG8494WBH)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Egg Phospholipids (UNII: 1Z74184RGV)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43199-054-151 in 1 CARTON09/14/201508/01/2019
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 43199-054-301 in 1 CARTON09/14/201508/01/2019
230 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/14/201508/01/2019
Labeler - County Line Pharamceuticals (015585278)

Revised: 1/2019
Document Id: 3f02d35d-cfb3-4210-3a68-2b8f6a76dc44
Set id: bf08d3c1-f3ef-4307-ba99-b20e31a3e8f0
Version: 3
Effective Time: 20190111