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 Discount Drug Mart, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each gram)

Benzocaine 20%

Purpose

Oral Pain Reliever

Uses

for the temporary relief of pain due to

• toothaches
• canker sores
• minor injury of the mouth and gums
• minor irritation of the mouth and gums caused by dentures
  

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

Flammable: keep away from fire or flame. Avoid smoking during application and until this product has dried.

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 or allergic reaction, get medical help or contact a Poison Control Center right away.

Directions

Directions cut open tip of tube

• 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

Inactive ingredients

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

Other Information

• do not use if tube tip is cut prior to opening
• 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

PRINCIPAL DISPLAY PANEL

Discount Drug Mart Oral Pain Relief

INGREDIENTS AND APPEARANCE

ORAL PAIN RELIEF 
oral pain reliever gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53943-996
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: 53943-996-42	1 in 1 CARTON	11/09/2015
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	11/09/2015

Labeler - Discount Drug Mart, Inc. (047741335)