INSECT BITE RELIEF - benzocaine liquid 
Swabplus Inc.

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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Insect Bite Relief Swab

Drug Fact

Active ingredient

Benzocaine 15%

Purpose: Benzocaine for  Pain Relief

Use: temporary relief of pain and itching associated with insect bites, scrapes, minor cuts, minor burns, sunburn, or skin irritation.

Warnings

For external use only. do not bandage.

Do not use. in the eyes or apply over large areas of the body. particularly over raw surfaces or blistered area - if product gets into the eyes. flush throughly with water and obtain medical attention. longer than one week unless directed by doctor.


Stop use and ask a doctor if. condition worsens or if symptoms periist for more than 7 days or clear up and occur again within a few days.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions. Do not use if label seal is broken prior to purchase. Keep swabs in original container when not in use.

For adult and children 2 and older. Apply directly onto affected area no more than 3 to 4 times daily.

Children under 2 years of age. Do not use, consult a doctor.

Other information. Avoid storing at excessive heat.

Aloe Vera Gel. Diazolidinyly Urea, Glycerin, Menthol, Methylparaben, Peg-8, Propylene Glycol, Propylparaben.

Image of insect bite carton label

Image of insect bite carton label

INSECT BITE RELIEF  
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65734-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 
Butylene Glycol 
Glycerin 
PROPYLENE GLYCOL 
ALOE VERA LEAF 
Triclosan 
Menthol 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65734-300-365 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/01/2003
Labeler - Swabplus Inc. (876441549)
Registrant - Swabplus Inc. (876441549)
Establishment
NameAddressID/FEIBusiness Operations
Swabplus Inc.876441549manufacture(65734-300)

Revised: 2/2013
Document Id: d24ed1ab-26d1-46d6-ba13-90eebdfeeada
Set id: d62d3f6e-3b1e-4ebf-88b6-35353423e55a
Version: 3
Effective Time: 20130204
 
Swabplus Inc.