Drug Facts

ORAL GEL MAXIMUM STRENGTH- benzocaine gel
Budpak Inc.

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
Anesthetic

Uses for the temporary relief of pain associated with:

toothache
canker sores
cold sores
fever blisters
minor dental procedures

Warnings

do not use for more than 7 days unless directed by a dentist or a doctor
if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics

When using this product

avoid contact with the eyes
do not exceed recommended dosage

Stop using and ask a doctor

sore mouth symptoms do not improve in 7 days
swelling, rash or fever develops
irritation, pain or redness persists or worsens

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions adults and children 2 years of age and older:

cut open tip of tube
apply to the 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, there is no recommended dosage except under the advice and supervision of a dentist or a doctor

Other information

store at room temperature
Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredients Purified water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Carbomer, Sorbic Acid, Methylparaben, Propylparaben, FDC Yellow 5, FDC Red 40

Package Label

ORAL GEL MAXIMUM STRENGTH
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:27293-012
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBIC ACID (UNII: X045WJ989B)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

#	Item Code	Package Description
Packaging
1	NDC:27293-012-01	1 in 1 BOX
1	NDC:27293-012-14	14 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/01/2010

Labeler - Budpak Inc. (183224849)

Name	Address	ID/FEI	Business Operations
Establishment
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.		529836561	manufacture