ORAL ANESTHETIC LIQUID- benzocaine liquid

Oral Anesthetic Liquid by

Drug Labeling and Warnings

Oral Anesthetic Liquid by is a Otc medication manufactured, distributed, or labeled by Meijer, Inc., Lornamead, HK KOLMAR CANADA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzocaine 20.0% (w/w)

Purpose

Oral pain reliever

Uses

Temporarily relieves pain associated with the following mouth and gum irritations:

• toothache
• sore gums
• canker sores
• braces
• minor dental procedures
• dentures

Warnings

METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a rare but serious confition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

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

• for teething
• in children under 2 years of age

When using this product

• avoid contact with eyes
• do not exceed recommended dosage
• do not use for more than 7 days unless directed by a dentist or doctor

Stop use and ask doctor if

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

Directions

Adults and children 2 years of age and older: wipe liquid on with cotton, or cotton swab, or fingertip, apply to the affected area up to 4 times daily or as directed by a doctor/dentist

• children under 12 years of age: adult supervision should be given in the use of this product
• children under 2 years of age: do not use
• for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting

Inactive ingredients

Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

Keep out of reach of children

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORAL ANESTHETIC LIQUID 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79481-0118
Route of Administration	ORAL

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)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	orange (dark orange/red to brown)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79481-0118-9	1 in 1 CARTON	02/05/2024
1		14.7 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	02/05/2024

Labeler - Meijer, Inc. (006959555)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
HK KOLMAR CANADA, INC		243501959	manufacture(79481-0118) , pack(79481-0118)