CaineTips

Manufacturer
J MORITA USA INC
Effective date
2023-09-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:56:17

Label at a glance#

ProductCaineTips
Active ingredientBENZOCAINE
Label structure9 sections

Indications and uses

For temporary relief of pain due to: minor dental procedures, minor mouth and/or gum irritation caused by dentures or orthodontic appliances, Vincent's infection, or canker sores.

Dosage and administration

HOLD WITH SOLID WHITE TIP STRAIGHT DOWN; BEND AND SNAP OPEN UPPER TIP AT COLORED RING; ALLOW MEDICINE TO FLOW DOWN. APPLY PRODUCT TO INTENDED AREA; ALLOW IT TO REMAIN IN PLACE AT LEAST 1 MINUTE AND THEN REMOVE IT FROM MOUTH; DISPOSE AFTER APPLICATION. USE UP TO 4 TIMES DAILY, OR AS DIRECTED BY A DENTIST. ADULT SUPERVISION REQUIRED FOR USE WITH CHILDREN UNDER 12 YEARS. CONSULT A DENTAL PROFESSIONAL FOR USE WITH CHI...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

BENZOCAINE 20%

PURPOSE

OTC - PURPOSE SECTION

PAIN RELIEVER

USES

INDICATIONS & USAGE SECTION

For temporary relief of pain due to: minor dental procedures, minor mouth and/or gum irritation caused by dentures or orthodontic appliances, Vincent's infection, or canker sores.

WARNINGS

WARNINGS SECTION

Do not use: if patient is allergic to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics;
exceeding recommended dosage for more than 7 days unless directed by a dentist; 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 a
dentist or a physician promptly.

PREGNANCY SECTION

If pregnant or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

HOLD WITH SOLID WHITE TIP STRAIGHT DOWN; BEND AND SNAP OPEN UPPER TIP AT COLORED RING; ALLOW MEDICINE TO FLOW DOWN.

APPLY PRODUCT TO INTENDED AREA; ALLOW IT TO REMAIN IN PLACE AT LEAST 1 MINUTE AND THEN REMOVE IT FROM MOUTH; DISPOSE AFTER APPLICATION.

USE UP TO 4 TIMES DAILY, OR AS DIRECTED BY A DENTIST. ADULT SUPERVISION REQUIRED FOR USE WITH CHILDREN UNDER 12 YEARS. CONSULT A DENTAL PROFESSIONAL FOR USE WITH CHILDREN UNDER 2 YEARS.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ARTIFICIAL FLAVOR, POLYETHYLENE GLYCOL, ETHOXY DIGLYCOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Canine Tips_Drug Facts BoxCanine Tips_Drug Facts Box

Canine Tips_Product ImageCanine Tips_Product Image

caninetips_ps_0809_v1caninetips_ps_0809_v1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
798072benzocaine 20 % Medicated PadPSN7
798072benzocaine 200 MG/ML Medicated PadSCD7
798072benzocaine 20 % Mucous Membrane Medicated SwabSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70769-101-512025-01-30C16284748780-12cef2736-b6bd-d83d-e063-dadaa90ab31fJ MORITA USA - CAINE TIPS (70769-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70769-101-11CaineTips0.15 mL in 1 APPLICATORLIQUID0.157
70769-101-51CaineTips100 in 1 BOXLIQUID1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70769-101CAINETIPS (BENZOCAINE) LIQUID [J MORITA USA INC]7Legacy NDC, 2 package rows20230923_0b5b73cc-5c43-49a8-9e36-a23391f766df.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70769-10170769-101-11, 70769-101-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
05f421d7-ff98-881c-e063-6394a90a4e990b5b73cc-5c43-49a8-9e36-a23391f766df2023-09-22WarningsExact identifier
spl id: 05f421d7-ff98-881c-e063-6394a90a4e99
spl set id: 0b5b73cc-5c43-49a8-9e36-a23391f766df

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.