ORAL PAIN RELIEF- oral pain reliever gel

Oral Pain Relief by

Drug Labeling and Warnings

Oral Pain Relief by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active ingredient (in each gram)

Benzocaine 20%

Purpose

Oral Pain Reliever

Uses

temporarily relieves pain due to toothaches

PRINCIPAL DISPLAY PANEL

Orajel         gel

Instant Pain Relief

for TOOTHACHE

MAXIMUM STRENGTH

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

INGREDIENTS AND APPEARANCE

ORAL PAIN RELIEF 
oral pain reliever gel

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0058-4	1 in 1 CARTON	07/17/2011
1		11.9 g in 1 TUBE; Type 0: Not a Combination Product

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)