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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67510-0058
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (Benzocaine)	Benzocaine	200 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
polyethylene glycol
SACCHARIN SODIUM
sorbic acid
glycerin

Packaging
#	Item Code	Package Description
1	NDC:67510-0058-4	1 TUBE (TUBE) in 1 CARTON
1		11.9 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/17/2011

Labeler - Kareway Product, Inc. (121840057)

Revised: 07/2011

Document Id: 9e235599-4d71-41b1-8743-d647468b19f9

Set id: b5d833d9-e367-4927-8e4f-790ad41d2502

Version: 1

Effective Time: 20110717

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Oral Pain Relief

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