BUDPAK ORAL MAXIMUM STRENGTH- benzocaine gel

Budpak Oral Maximum Strength by

Drug Labeling and Warnings

Budpak Oral Maximum Strength by is a Otc medication manufactured, distributed, or labeled by Budpak Inc., Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzocaine 20%

PURPOSE

Purpose

Anesthetic

INDICATIONS & USAGE

Uses

for the temporary relief of pain associated with:

• toothache
• canker sores
• cold sores
• fever blisters
• minor dental procedures

WARNINGS

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

When using this product

• avoid contact with the eyes
• do not exceed recommended dosage

STOP USE

Stop using this product 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 OUT OF REACH OF CHILDREN

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

adults and children 2 years of age and older:

• break seal on tube
• apply to the affected area up to 4 times daily or as directed by a dentist or a 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

SPL UNCLASSIFIED SECTION

Other Information

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

INACTIVE INGREDIENT

Inactive Ingredients

Ammonium Glycyrrhizate, Polyethylene glycol, Saccharin sodium, Sorbic acid, Flavor

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

ORAL MAXIMUM STRENGTH PAIN RELIEF GEL

Benzocaine 20%

Anesthetic

NET WT 0.5 OZ (14 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK ORAL MAXIMUM STRENGTH 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-019-01	1 in 1 BOX
1	NDC: 27293-019-14	14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/10/2013

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-019)