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Lidocaine by County Line Pharamceuticals

Dosage form: cream
Ingredients: Lidocaine 50mg in 1g
Labeler: County Line Pharamceuticals
NDC Code: 43199-054

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.

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

LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43199-054
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (Lidocaine) Lidocaine50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) 
Propylene Glycol 
Benzyl Alcohol 
.Alpha.-Tocopherol Acetate 
Egg Phospholipids 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:43199-054-151 TUBE in 1 CARTON
115 g in 1 TUBE
2NDC:43199-054-301 TUBE in 1 CARTON
230 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34609/14/2015
Labeler - County Line Pharamceuticals (015585278)
Establishment
NameAddressID/FEIOperations
Ei LLC105803274manufacture(43199-054), analysis(43199-054)

 
County Line Pharamceuticals

← See all Lidocaine brands

Medically reviewed on Nov 27, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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