ORAL PAIN RELIEF ANESTHETIC ANESTHETIC- benzocaine gel
Major Pharmaceuticals

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

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

ORAL PAIN RELIEF ANESTHETIC ANESTHETIC
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6021
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-6021-36	1 in 1 CARTON	08/19/2009	05/31/2013
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/19/2009	05/31/2013

Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2019

Document Id: d1e903db-cad3-4282-8c38-5518be9caa47

Set id: d5cfed2d-c080-484c-bc8e-89f6f5da8023

Version: 2

Effective Time: 20191001

Major Pharmaceuticals