ADVENTURE MEDICAL KITS DENTAL MEDIC- benzocaine 
Tender 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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Adventure Medical Kits Dental Medic

Active Ingredient - Oral Pain Relief

Benzocaine 20%

Purpose - Oral Pain Relief

Oral Pain Reliever

Uses - Oral Pain Reliever

Temporarily relieves pain caused by: toothache, dental work, minor irritation or injury of the mouth and gums, canker sores, cheek bites, gum sores, and denture irritation.

Warnings - Oral Pain Relief

For oral use only. Avoid contact with eyes.

Allergy alert

Do not use this product if you have a history of allergy to local anesthetics, such as procaine, butacaine, benzocaine, or other “caine” anesthetics due to the possibility of anaphylactic shock.

When using this product

Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

Keep out of reach of children

If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions - Oral Pain Relief

Adults and children 2 years and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.

Consult a dentist or doctor for use on children under 2 years of age

Children under 12 years of age should be supervised in the use of this product

Other Information - Oral Pain Relief

Do not use if packet is torn, cut, or opened

Store at room temperature, 15º to 30ºC (59º to 86ºF)

Avoid contact with eyes

Inactive Ingredients - Oral Pain Relief

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

Keep out of Reach of Children

Keep out of Reach of Children

Adventure Medical Kits Dental Medic

Dental MedicDental MedicOral Pain Relief

ADVENTURE MEDICAL KITS DENTAL MEDIC 
benzocaine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-0102
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44224-0102-01 in 1 BAG; Type 0: Not a Combination Product09/19/2012
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 PACKET 2 g  in .5 
Part 1 of 1
PAIN RELIEF 
benzocaine liquid
Product Information
Item Code (Source)NDC:61010-8100
Route of AdministrationTOPICAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-8100-20.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/19/2012
Labeler - Tender Corporation (064437304)
Registrant - Tender Corporation (064437304)
Establishment
NameAddressID/FEIBusiness Operations
Tender Corporation064437304manufacture(44224-0102)

Revised: 3/2017
Document Id: 4adc9c0d-9ef3-281b-e054-00144ff8d46c
Set id: 4adc9c0d-9ef2-281b-e054-00144ff8d46c
Version: 1
Effective Time: 20170316
 
Tender Corporation