LEADER ORAL PAIN RELIEF ANESTHETIC- benzocaine 20% gel 
Cardinal Health

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.

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Drug Facts

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

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

Stop use and ask a Doctor if:

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

Inactive Ingredients

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

Maximum Strength

Oral Pain Relief

Anesthetic Gel

ORAL PAIN RELIVER

BENZOCAINE 20%

0.5OZ (14.2G)

carton imageimage of carton lable

Maximum Strength

Oral Pain Relief

Anesthetic Gel

ORAL PAIN RELIVER

BENZOCAINE 20%

0.5OZ (14.2G)

tube imageimage of tube lable

LEADER ORAL PAIN RELIEF  ANESTHETIC
benzocaine 20% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-607
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
Sorbic Acid (UNII: X045WJ989B)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-607-061 in 1 CARTON
1NDC:37205-607-0514.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35608/08/2012
Labeler - Cardinal Health (097537435)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health097537435label(37205-607)
Establishment
NameAddressID/FEIBusiness Operations
Lee Pharmaceuticals056425432pack(37205-607)
Establishment
NameAddressID/FEIBusiness Operations
Unipack009248480manufacture(37205-607)

Revised: 8/2012
Document Id: de03e285-4967-460e-8843-0b874dd1d203
Set id: 72274fff-065b-4c87-9207-68ee8a537618
Version: 11
Effective Time: 20120824
 
Cardinal Health