AMERICAINE- benzocaine ointment 
Insight Pharmaceuticals LLC

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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Americaine Hemorrhoidal Ointment

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Hemorrhoidal Ointment

Uses

temporarily relieves these symptoms associated with hemorrhoids

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

Children under 12 years: ask a doctor

Other information

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)

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5.6 g  in 28 g
Inactive Ingredients
Ingredient NameStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
Product Characteristics
ColorWHITE (clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-375-011 in 1 BOX07/10/2009
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34607/10/2009
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 1/2020
Document Id: 272a1b21-943a-4bbc-acfd-2a5e3433ef05
Set id: d13c022f-2f91-40b4-bd66-0cfc0e147a5f
Version: 4
Effective Time: 20200114
 
Insight Pharmaceuticals LLC