BENZOCAINE- benzocaine swab 
Dynarex Corporation

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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Benzocaine Sting and Bite

Active Ingredient

Active Ingredient  Purpose  

Benzocaine, 6% w/v                       Topical Analgesic


Purpose for Benzocaine

Keep Out of Reach of Children

Indications and Usage

Warnings

Warnings: Benzocaine


Dosage

Directions:

Inactive Ingredients

DO Not Use

Do not use:

With electrocautery procedures.

Stop Use

Stop use:

If irritation and redness develop.
If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Storage and Handling

Principal Display Panel

Dynarex Sting and Bite

Benzocaine.jpg

Benzocaine

BENZOCAINE 
benzocaine swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-246
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 60 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67777-246-01 2 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 07/20/2011
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
Name Address ID/FEI Business Operations
Phoenix Innovative Healthcare Manufacturers Private Limited 650687176 manufacture(67777-246)

Revised: 6/2015
Document Id: 28a96f0e-a39e-4fdc-beb5-cd6f08b912a2
Set id: 6161e94c-7849-466e-8da3-a6f1b085bdf9
Version: 13
Effective Time: 20150604
 
Dynarex Corporation