BENZ O STHETIC- benzocaine gel

Benz O Sthetic by

Drug Labeling and Warnings

Benz O Sthetic by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drugs Facts

Active Ingredients Purpose
Benzocaine 20% Anesthetic

Uses

For temporary relief of oral pain associated with: · toothache ·canker sores ·minor dental
procedures · minor injury of the mouth and gum caused by dentures or orthodontic appliances.

Directions

Apply with cotton applicator or finger tip to affected gum area
up to 4 times a day or as directed by your dentist.

DOSAGE & ADMINISTRATION

Do not use for more thatn 7 days.

Warnings

Do not use this product if you have a history of allergy to
local anesthetic such as Procaine, Benzocaine or other
“Caines”. Not recommended for children under the age of 2.

Other Ingredients

Benzyl Alcohol, Cherry Flavor, FD&C Red #40, PEG 3350, PEG 400, Sodium Saccharin

Storage

Store at controlled room temperature 20-25°C (68-77°F).

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZ O STHETIC 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-926
Route of Administration	TOPICAL

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
BENZYL ALCOHOL (UNII: LKG8494WBH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-926-15	15 g in 1 TUBE; Type 0: Not a Combination Product	07/31/2015
2	NDC: 54162-926-29	29 g in 1 TUBE; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/31/2015

Labeler - Geritrex LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	manufacture(54162-926)