CAINETIPS- benzocaine liquid 
J MORITA USA INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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J MORITA USA - CAINE TIPS (70769-101)

ACTIVE INGREDIENT

BENZOCAINE 20%

PURPOSE

PAIN RELIEVER

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.

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.

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

Keep out of reach of children.

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.

INACTIVE INGREDIENTS

ARTIFICIAL FLAVOR, POLYETHYLENE GLYCOL, ETHOXY DIGLYCOL

Canine Tips_Drug Facts Box

Canine Tips_Product Image

caninetips_ps_0809_v1

CAINETIPS 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70769-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70769-101-51100 in 1 BOX06/06/2016
1NDC:70769-101-110.15 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/06/2016
Labeler - J MORITA USA INC (021866033)

Revised: 9/2023
Document Id: 05f421d7-ff98-881c-e063-6394a90a4e99
Set id: 0b5b73cc-5c43-49a8-9e36-a23391f766df
Version: 7
Effective Time: 20230922
 
J MORITA USA INC