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Benzocaine by Church & Dwight Co., Inc.

Medically reviewed on March 28, 2017

Dosage form: liquid
Ingredients: BENZOCAINE 200g in 1mg, MENTHOL 10g in 1mg
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-767

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.

Orajel Maximum Toothache Liquid

Benzocaine 20%

Menthol 0.1%

Oral Pain Reliever

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

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

Flammable: keep away from fire or flame. Avoid smoking during application and until this product has been dried

Do not use • more than directed • for more than 7 days unless directed by a physician or healthcare provider

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 • allergic reaction occurs

Keep out of reach of children.

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

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 a day or ad directed by a physician or healthcare provider

Children under 12 years of age

Should be supervised in the use of this product

Children under 2 years of age

Ask a physician or healthcare provider

Other Information • do not use if imprinted bottle seal is broken or missing prior to opening • do not continuously

Inactive Ingredients alcohol (54.5% by volume), flavor, polyehtylene glycol, red 40, sodium saccarin, water, yellow 5

Questions or comment? Call us at 800 952 5080 Mon thru Fri 9-5 or visit our website at www orajel com

#1

ORAL PAIN

RELIEVER BRAND

FOR TOOTHACHE

2X MORE

Active

Ingredients*

Orajel

Instant Pain Relief

SEVERE

Toothache & Gum Relief Plus

DOUBLE MEDICATED

20 % Benzocaine to Relieve Oral Pain

Menthol to Soothe Gums

FAST-ACTING

LIQUID

ORAL PAIN RELIEVER 0.45 FL OZ (13.3mL)

BENZOCAINE 
orajel severe toothache liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-767
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 g  in 1 mg
MENTHOL (MENTHOL) MENTHOL10 g  in 1 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 5 
ALCOHOL 
SACCHARIN SODIUM 
FD&C RED NO. 40 
WATER 
Product Characteristics
ColororangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10237-767-451 BOTTLE, GLASS in 1 CARTON
113.3 mg in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/24/2017
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Accupac071609663manufacture(10237-767)

 
Church & Dwight Co., Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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