MOUTH SORE MEDICATION- benzocaine liquid

Mouth Sore Medication by

Drug Labeling and Warnings

Mouth Sore Medication by is a Otc medication manufactured, distributed, or labeled by Zee Medical, Safetec of America, Inc., Safetec Of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

COMPARE TO THE ACTIVE INGREDIENT IN KANK-A®

ZEE MOUTH SORE MEDICATION

ORAL PAIN RELIEVER

Fast Mouth Sore Relief

• Canker sores
• Gum Pain
• Toothache
• Dental Work

25 Packets

0.5g (0.017 oz) per packet

DO NOT USE IF PACKET IS TORN OR OPEN

Drug Facts

Active ingredient

Benzocaine 20% (w/w)

Purpose

Oral pain reliever

Uses

temporarily relieves pain caused by

• toothache
• canker sores
• gum sores
• dental work
• cheek bites
• denture irritation
• minor irritation or injury of the mouth and gums

Warnings

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

WHEN USING

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 e in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

KEEP OUT OF REACH OF CHILDREN

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

• adults and children 2 years and older: dry affected area and apply medication. Use up to 4 times daily, but not more than every 2 hours, or as directed by a dentist or doctor.
• children under 12 years of age should be supervised in the use of this product
• children under 2 years of age: ask a dentist or doctor

Inactive ingredients

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

Questions?

1-800-841-8417

Distributed by
Zee Medical, Inc., Irvine,CA 92606
This product is not manufactured or distributed by Blistex, Inc., distributor of KANK-A® Mouth Pain Liquid

PRINCIPAL DISPLAY PANEL – packet label

DO NOT USE IF PACKET IS TORN OR OPEN

MOUTH SORE ZEE

MEDICATION

Oral Pain Reliever

Fast Mouth Sore Relief

• Canker sores
• Gum Pain
• Toothache
• Dental Work

5g (0.017 oz)

PRINCIPAL DISPLAY PANEL – Carton label

NDC: 35418-631-01

COMPARE TO THE ACTIVE INGREDIENT IN KANK-A®*

ZEE MOUTH SORE MEDICATION

ORAL PAIN RELIEVER

Fast Mouth Sore Relief

• Canker sores
• Gum Pain
• Toothache
• Dental Work

25 Packets

0.5g (0.017 oz) per packet

INGREDIENTS AND APPEARANCE

MOUTH SORE MEDICATION 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35418-631
Route of Administration	TOPICAL

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
polyethylene glycol 400 (UNII: B697894SGQ)
polyethylene glycol 3350 (UNII: G2M7P15E5P)
peppermint oil (UNII: AV092KU4JH)
saccharin sodium dihydrate (UNII: SB8ZUX40TY)
sorbic acid (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35418-631-01	25 in 1 BOX
1		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

Labeler - Zee Medical (009645623)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec Of America, Inc.		874965262	MANUFACTURE(35418-631)