LEADER ORAL ANALGESIC- benzocaine gel

LEADER ORAL ANALGESIC by

Drug Labeling and Warnings

LEADER ORAL ANALGESIC by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                Purpose

Benzocaine 20%................................................................Oral Pain Reliever

PURPOSE

Uses

• temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums cause by dentures or orthodontic appliances

WARNINGS

Warnings

Allergy alert: do not use this product if you have a history of allergic to local anesthetics such as procaine, butacaine, benzocaine, or other caine anesthetics

DO NOT USE

Do not use

• more than directed
• for more than 7 days unless directed by a doctor/dentist

STOP USE

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

Keep out of reach of children.

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Directions

• remove cap and cut tip of tube on score mark
• adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a doctor or dentist
• children under 12 years of age: should be supervised when using this product
• children under 2 years of age: ask a doctor/dentist

STORAGE AND HANDLING

Other information

• store at 15o to 25oC (59o to 77oF)
• do not use if tube tip is cut prior to opening
• this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist can be consulted
• do not use continuously
• Lot no and Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

d-sorbitol solution, flavor, glycerin, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium hydrate

DOSAGE & ADMINISTRATION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER ORAL ANALGESIC 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-122
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-122-12	1 in 1 CARTON	10/11/2016
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 final	part333B	05/01/2012

Labeler - CARDINAL HEALTH (097537435)