J Morita Usa - Caine Tips (70769-101)

J Morita Usa - Caine Tips (70769-101)
SPL v7
SPL
SPL Set ID 0b5b73cc-5c43-49a8-9e36-a23391f766df
Route
ORAL
Published
Effective Date 2016-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Polyethylene Glycol 1000 Diethylene Glycol Monoethyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-06-06

Description

BENZOCAINE 20%

Purpose

PAIN RELIEVER


Medication Information

Purpose

PAIN RELIEVER

Description

BENZOCAINE 20%

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.

Section 42228-7

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

Section 50565-1

Keep out of reach of children.

Section 51945-4

Warnings

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.

Directions

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.

Active Ingredient

BENZOCAINE 20%

Inactive Ingredients

ARTIFICIAL FLAVOR, POLYETHYLENE GLYCOL, ETHOXY DIGLYCOL


Structured Label Content

Uses (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.

Section 42228-7 (42228-7)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

PAIN RELIEVER

Warnings (WARNINGS)

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.

Directions (DIRECTIONS)

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.

Active Ingredient (ACTIVE INGREDIENT)

BENZOCAINE 20%

Inactive Ingredients (INACTIVE INGREDIENTS)

ARTIFICIAL FLAVOR, POLYETHYLENE GLYCOL, ETHOXY DIGLYCOL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)