MEDICAINE STING AND BITE- benzocaine swab 
James Alexander 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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MEDICAINE STING® & BITE SWABS

Drug Facts

Active Ingredients (each swab)

Benzocaine USP (20%), L-Menthol USP (1%)

Purpose

analgesic

Uses

For temporary relief of pain and itching associated with insect bites and stings.

Warnings

For external use only

Stop use and ask a doctor if condition for this preparation is used persists, or if a rash or irritation or allergic reaction develops.

Keep out of reach of children. Not for use with children less than 2 years old without medical advice. If swallowed, get medical help immediately or contact a Poison Control Center right away.

Directions

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Once solution has saturated tip, apply topically to the sting or bite. May be used on affected area(s) up to 4 times per day.

Other Information

Store at room temperature away from light.

Inactive Ingredients

D&C Green Dye #5, D&C Yellow Dye #10, FD&C Blue Dye #1, PEG 300 NF, Isopropyl Alcohol USP, Purified Water USP.

Questions?

Call 1-908-362-9266 Monday through Friday, 9:00am - 5:00pm e.s.t

DISPENSING SOLUTIONS®

JAMES ALEXANDER CORPORATION

Blairstown, NJ. (908) 362-9266

Product information and MSDS available on-line at:

www.james-alexander.com

Void of Aqueous

Packaging

image description

MEDICAINE STING AND BITE 
benzocaine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46414-2040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) BENZOCAINE0.12 g  in 0.6 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.006 g  in 0.6 mL
Inactive Ingredients
Ingredient NameStrength
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46414-2040-36 mL in 1 CARTON; Type 0: Not a Combination Product11/15/1986
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/15/1986
Labeler - James Alexander Corporation (040756421)
Registrant - James Alexander Corporation (040756421)
Establishment
NameAddressID/FEIBusiness Operations
James Alexander Corporation040756421manufacture(46414-2040)

Revised: 1/2019
Document Id: 696bc572-65fb-483b-9d84-adef41d1440c
Set id: 753e6cbe-31e0-4017-93d0-8b4bf5972f37
Version: 4
Effective Time: 20190131
 
James Alexander Corporation