BENZOCAINE- orajel severe toothache liquid

Benzocaine by

Drug Labeling and Warnings

Benzocaine by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., Accupac. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzocaine 20%

Menthol 0.1%

PURPOSE

Oral Pain Reliever

INDICATIONS & USAGE

Use for the temporary relief of pain due to canker sores minor injury of the mouth and gum minor irritation of the mouth and gums caused by dentures or orthodontic appliances

WARNINGS

Methemoglobinemia warning: Use of this product may cuse methemoglobinemia, a serious condition that must be treated promptly becasue it reduces the amount of oxygen carried in the 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 or breath dizziness or lightheadedness fatigue or lack of engery

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

Flammable: keep away from fire or flame. Avoid smoking during application.

DO NOT USE

Do not use more than directed for more than 7 days unless directed by a dentistor doctor for teething in children under 2 years of age

STOP USE

Stop use and ask a physician if swelling, rash or fever develops irritation, pain or redness persists or worsens symptoms do not improve in 7 days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions remove imprinted safety seal from bottle cap

Adults and children 2 years of age and over

• Apply product with cotton swab or finger to the affected area. Use up to 4 times daily or as directed by a dentist or doctor

Children under 12 years of age

• Ask a doctor before use. Should be supervised in the use of this product

Children under 2 years of age

• Do not use

Other Information do not use if safety seal on bottle cap is broken or missing prior to opening

INACTIVE INGREDIENT

Inactive Ingredients alcohol (54.5% by volume), flavor, PEG-8, red 40, sodium saccarin, water, yellow 5

QUESTIONS

Questions or comment? Call us at 800 952 5080 M-F 9am-5pm or visit our website at www orajel.com

PRINCIPAL DISPLAY PANEL

#1

ORAL PAIN

RELIEVER BRAND

FOR TOOTHACHE

Fast-Acting Liquid!

Orajel

MEDICATED

FOR TOOTHACHE & GUM

Instant Pain Relief

20% Benzocaine to Relieve Oral Pain

Menthol to Soothe Gums

CANKER SORES CHEEK BITES DENTURE PAIN

IRRITATION FROM BRACES

ORAL PAIN RELIEVER

0.45 FL OZ (13.3mL)

OJFC-32945-07

INGREDIENTS AND APPEARANCE

BENZOCAINE 
orajel severe toothache liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-777
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 g  in 1 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALCOHOL (UNII: 3K9958V90M)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-777-45	1 in 1 CARTON	07/31/2019
1		13.3 mg in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/31/2019

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac		071609663	manufacture(10237-777)