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Americaine by Insight Pharmaceuticals

Dosage form: ointment
Ingredients: Benzocaine 5.6g in 28g
Labeler: Insight Pharmaceuticals
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 right away.

Directions
  • 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 Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - Tube Carton

Americaine®
Hemorrhoidal Ointment

Benzocaine
Maximum Strength Hospital Formula

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 (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 (176792315)

Revised: 07/2009
 
Insight Pharmaceuticals

See Also

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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