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Insect Bite Relief

Dosage form: solution
Ingredients: Benzocaine 150mg in 1mL
Labeler: Swabplus Inc.
NDC Code: 65734-300

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.

Insect Bite Relief Swabs

Drug Fact

Active ingredient

Benzocaine 15%

Purpose

Benzocaine for  Pain Relief

Uses

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 persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children

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.

Administration

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.

Inactive ingredients

Aloe Vera Gel. Ethoxydiglycol (diethylene glycol monoethyl ether), Glycerin, Menthol, PEG-8 (Polyethylene glycol 400), Propylene Glycol, Triclosan

Package Display Panel

Image of insect bite carton label

INSECT BITE RELIEF 
benzocaine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine150 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 
DIETHYLENE GLYCOL MONOETHYL ETHER 
Glycerin 
PROPYLENE GLYCOL 
ALOE VERA LEAF 
Triclosan 
Menthol 
Packaging
#Item CodePackage Description
1NDC:65734-300-3636 APPLICATOR in 1 PACKAGE
1NDC:65734-300-000.15 mL in 1 APPLICATOR
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/FEIOperations
Swabplus Inc.876441549manufacture(65734-300), relabel(65734-300), repack(65734-300)

Revised: 04/2013
 
Swabplus Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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