Pill Identifier App

Oral Pain Relief

Dosage form: gel
Ingredients: Benzocaine 200mg in 1g
Labeler: Kareway Product, Inc.
NDC Code: 67510-0058

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.

Drug Facts

Warnings

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

Do not use    more than directed            for more than 7 days unless told to do so by a dentist or doctor

Stop use and ask a doctor if    swelling, rash or fever develops; irritation, pain or redness persists or worsens; symptoms do not improve in 7 days


Keep out of reach of children:

in case of overdose, get medical help or contact a Poison Control Center right away

Directions

Directions   do not use if tube tip is cut prior to opening; cut open tip of tube on score mark

Adults and children 2 years of age and over                  Apply a small amount of product to the cavity and around gum surrounding the teeth.
                                                                                 Use up to 4 times daily 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



Other information
This preparation is intended for use in case of toothache, only as a temporary expedient until a dentist can be consulted;
do not use continuously

Inactive ingredients

Inactive ingredients  polyethylene glycol, glycerin, sodium saccharin, sorbic acid, flavor

Orajel         gel

Instant Pain Relief

for TOOTHACHE

MAXIMUM STRENGTH



NE WT 0.42 OZ (11.9 g)     ORAL PAIN RELIEVER   BENZOCAINE 20%



Active ingredient (in each gram)

Benzocaine 20%

Purpose

Oral Pain Reliever

Uses

temporarily relieves pain due to toothaches

ORAL PAIN RELIEF 
oral pain reliever gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0058
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Benzocaine) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
polyethylene glycol 
SACCHARIN SODIUM 
sorbic acid 
glycerin 
Packaging
#Item CodePackage Description
1NDC:67510-0058-41 TUBE (TUBE) in 1 CARTON
111.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/17/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 07/2011
 
Kareway Product, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)