Your browser does not support JavaScript! INSECT BITE RELIEF (BENZOCAINE) LIQUID [SWABPLUS INC.]
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INSECT BITE RELIEF (benzocaine) liquid
[Swabplus Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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.

  • Hold the swab vertically, with the color band tip upwards. hold in the center of the stem with one hand and at the color band with the other.
  • Bend the tip at the color band to one side until it snaps.
  • Apply the product to the affected area.
  • Discard swab after 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
 
Swabplus Inc.

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