LEADER ORAL PAIN RELIEF ANESTHETIC- benzocaine 20% gel

Leader Oral Pain Relief by

Drug Labeling and Warnings

Leader Oral Pain Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Lee Pharmaceuticals, Unipack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzocaine, 20%

Purpose

Oral pain reliever

Uses

For the temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic appliances.

WARNINGS

Warnings

INDICATIONS & USAGE

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

Do Not Use

• more than directed

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

STOP USE

Stop use and ask a Doctor if:

• swelling, rash, or fever develops

• irritation, pain or redness persists or gets worse

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Cut open tip of tube.

Adults and children 2 years of age and older, apply to affected area 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 the product.

Children under 2 years of age, consult a doctor.

Other Information

• Do not use if tube tip is cut prior to opening.
• Store at room temperature.
  

Inactive Ingredients

Flavors, PEG 4, PEG 540, PEG 75, PEG 8, Sodium Saccharin, Sorbic Acid.

PRINCIPAL DISPLAY PANEL

Maximum Strength

Oral Pain Relief

Anesthetic Gel

ORAL PAIN RELIVER

BENZOCAINE 20%

0.5OZ (14.2G)

carton image

PRINCIPAL DISPLAY PANEL

Maximum Strength

Oral Pain Relief

Anesthetic Gel

ORAL PAIN RELIVER

BENZOCAINE 20%

0.5OZ (14.2G)

tube image

INGREDIENTS AND APPEARANCE

LEADER ORAL PAIN RELIEF  ANESTHETIC
benzocaine 20% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-607
Route of Administration	ORAL

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
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
Sorbic Acid (UNII: X045WJ989B)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-607-06	1 in 1 CARTON
1	NDC: 37205-607-05	14.2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part356	08/08/2012

Labeler - Cardinal Health (097537435)

Registrant - Lee Pharmaceuticals (056425432)

Establishment
Name	Address	ID/FEI	Business Operations
Cardinal Health		097537435	label(37205-607)

Establishment
Name	Address	ID/FEI	Business Operations
Lee Pharmaceuticals		056425432	pack(37205-607)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack		009248480	manufacture(37205-607)