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Americaine by Insight Pharmaceuticals LLC

Medically reviewed on April 20, 2018

Dosage form: ointment
Ingredients: BENZOCAINE 5.6g in 28g
Labeler: Insight Pharmaceuticals LLC
NDC Code: 63736-375

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.

Americaine Hemorrhoidal Ointment

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Hemorrhoidal Ointment

Uses

temporarily relieves these symptoms associated with hemorrhoids

  • inflammation
  • itching
  • local pain
  • soreness

Warnings

For external use only

When using this product
  • certain persons can develop allergic reactions to ingredients in this product
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • do not exceed dosage unless directed by a doctor

Stop use and ask a doctor if
  • condition worsens or does not improve in 7 days
  • bleeding occurs
  • symptoms do not get better, or if redness, irritation, swelling, pain or other symptoms occur or increase

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults

  • when practical, cleanse affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.
  • apply externally to the affected area up to 6 times daily

Children under 12 years: ask a doctor

Other information
  • if ointment contacts clothing or other fabrics, wash in warm water only; do not use bleach.
  • store at room temperature 15°– 25°C (59°– 77°F)
  • tube is sealed for your protection. Do not use if foil seal is broken or missing.

Inactive ingredients

benzethonium chloride, polyethylene glycol 300, polyethylene glycol 3350.

QUESTIONS?

Call 1-800-344-7239 or visit our website at www.insightpharma.com

Distributed by: Insight Pharmaceuticals LLC

Tarrytown, NY 10591

A Prestige Brands Company 

PRINCIPAL DISPLAY PANEL:


Americaine® 
Benzocaine
Hemorrhoidal Ointment

NET WT. 1 OZ (28 G)

AMERICAINE 
benzocaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-375
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE5.6 g  in 28 g
Inactive Ingredients
Ingredient NameStrength
BENZETHONIUM CHLORIDE 
POLYETHYLENE GLYCOL 300 
POLYETHYLENE GLYCOL 3350 
Product Characteristics
ColorWHITE (clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63736-375-011 TUBE in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34607/10/2009
Labeler - Insight Pharmaceuticals LLC (055665422)

 
Insight Pharmaceuticals LLC

See Also

Further information

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

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