Mouth Sore Medication
FDA Label NDC 35418-631

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zee Medical for the product Mouth Sore Medication (NDC 35418-631). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - when using, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel – Packet Label

→ Principal Display Panel – Carton Label

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