Blistex: Package Insert and Label Information

BLISTEX — benzocaine bead
Blistex Inc.

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.

Drug Facts

Active ingredient Purpose

Benzocaine 3mg per bead Oral Anesthetic

Uses

For the temporary relief of pain due to canker sores, minor dental procedures,

dentures or orthodontic appliances, or minor irritation or injury of the mouth or gums.

Warnings

For oral use only

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 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 or fever develops, see your doctor or dentist promptly.

Do not exceed recommended dosage.


Keep out of reach of children.
In cases of overdose, get medical help or
contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older

for all over discomfort, including multiple mouth sores,

brace or denture pain, oral abrasions or minor burns inside the mouth,

place 1 dose 5 beads , in mouth and circulate the mini beads until they dissolve.

for targeted pain relief from individual canker sores, accidental bites , etc.

place 1 dose 5 beads over the affected area and hold in place until dissolved.

may be repeated every 2 hours as needed or as directed by a dentist or a doctor.

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

children under 2 years of age : consult a dentist or doctor

Other Information

do not purchase if package has been opened

store in a cool, dry place, protect from moisture and humidity

Inactive Ingredients

caprylic capric triglyceride , eugenol , flavor ,

gelatin , glycerin , hydrogenated coco glycerides , PEG 90,

polysorbate 80 , sorbitol sucralose, sucrose acetate isobutyrate.

2009 Blistex, Inc.

P O Box 5392

Oak Brook, IL

60522 5392 42479

Product made in Japan

Printed in USA


Blistex
Carton is 100 percent Recyclable

KANK-A Soothing Beads


Convenient and easy to use wherever you are.
2 ways to use
Roll around mouth for all over relief
Hold in place for targeted relief

Professional Strength

Kank-A

Blistex

Soothing Beads

Benzocaine 3mg Oral Anesthetic

Smooth Dissolving Mouth Pain Beads

New

Maximum Pain Relief

Roll In Mouth for All Over Use

Place In One Spot For Targeted Use

Multiple Mouth Sores

Brace Denture Irritation

Gum Discomfort

Mouth Burns

Relief on the Go

15 Doses

75 Beads

3 mg each

KankaBeads
(click image for full-size original)

BLISTEX kank-a soothing beads bead
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10157-9434
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 3 mg
Inactive Ingredients
Ingredient Name Strength
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES
EUGENOL
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL
POLYSORBATE 80
SORBITOL
SUCRALOSE
SUCROSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10157-9434-1 75 BEAD (BEAD) in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 10/01/2009
Labeler — Blistex Inc. (005126354)
Registrant — Morishita Jintan Co., Ltd. (690541313)
Establishment
Name Address ID/FEI Operations
Morishita Jintan Co., Ltd. 690541313 manufacture

Revised: 09/2009 Blistex Inc.

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