SPL v2
SPL
SPL Set ID 2666b95e-667f-471a-9929-9deca27e9cbc
Route
TOPICAL
Published
Effective Date 2015-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol 400 Polyethylene Glycol 3350 Peppermint Oil Saccharin Sodium Dihydrate Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-05-01

Description

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

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

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

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
Section 42229-5

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

Section 50565-1

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.

Section 50567-7

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.

Warnings

For oral use only. Avoid contact with eyes.

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
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

Active Ingredient

Benzocaine 20% (w/w)

Inactive Ingredients

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

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

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)


Structured Label Content

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
Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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.

Section 50567-7 (50567-7)

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.

Purpose

Oral pain reliever

Warnings

For oral use only. Avoid contact with eyes.

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
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

Active Ingredient (Active ingredient)

Benzocaine 20% (w/w)

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel – Carton Label (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

Principal Display Panel – Packet Label (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)


Advanced Ingredient Data


Raw Label Data

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