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  5. Label Information: Mouth Sore Medication

FDA Label for Mouth Sore Medication

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - WHEN USING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. QUESTIONS?
    11. PRINCIPAL DISPLAY PANEL – PACKET LABEL
    12. PRINCIPAL DISPLAY PANEL – CARTON LABEL

Mouth Sore Medication Product Label

The following document was submitted to the FDA by the labeler of this product Zee Medical. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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

    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


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.


Otc - 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.


Otc - 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

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

* Please review the disclaimer below.