ADVENTURE MEDICAL KITS DENTAL MEDIC- benzocaine kit

Adventure Medical Kits Dental Medic by

Drug Labeling and Warnings

Adventure Medical Kits Dental Medic by is a Otc medication manufactured, distributed, or labeled by Tender Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ADVENTURE MEDICAL KITS DENTAL MEDIC 
benzocaine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44224-0102

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44224-0102-0	1 in 1 BAG; Type 0: Not a Combination Product	09/19/2012

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 PACKET	2 g  in .5

Part 1 of 1

PAIN RELIEF 
benzocaine liquid

Product Information
Item Code (Source)	NDC: 61010-8100
Route of Administration	TOPICAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-8100-2	0.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/19/2012

Labeler - Tender Corporation (064437304)

Registrant - Tender Corporation (064437304)

Establishment
Name	Address	ID/FEI	Business Operations
Tender Corporation		064437304	manufacture(44224-0102)