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Orajel Toothache Rinse by Church & Dwight Co., Inc.

Medically reviewed on Nov 16, 2016

Dosage form: liquid
Ingredients: BENZYL ALCOHOL 2.91mg in 1mL, ZINC CHLORIDE 1.62mg in 1mL
Labeler: Church & Dwight Co., Inc.
NDC Code: 10237-764

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 Toothache Rinse

Benzyl Alcohol 0.27%

Zinc Chloride 0.15%

Oral pain reliever

Oral astringent

Use for temporary relief of pain due to toothaches, minor irritation of the mouth and gums, occasional minor irritation, pain, sore mouth and sore throat

Warnings

Do not use this product for more than 7 days unless directed by a dentist or healthcare provider

When using this product • do not swallow • do not exceed recommended dosage

Stop use and see your physician promptly if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days • allergic reaction occurs • sore thoat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

remove imprinted safety seal from bottle cap

• to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed.

Adults and children 2 years of age or over:

Swish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider

Children under 12 years of age:

Should be supervised in the use of this product

Children under 2 years of age:

Consult a dentist or healthcare provider

Other Information • cap tightly • keep away from heat or direct sunlight • do not use if safety seal is broken or missing

Inactive Ingredients alcohol (4.1% by volume), blue 1, disodium pyrophosphate, menthol, methyl salicylate, poloxamer 338, polysorbate 20, sodium benzoate, sodium saccharin, sorbitol, tetrasodium pyrophosphate, water

Questions or comments calls us at 800 952 5080 Monday through Friday 9 to 5 ET or visit our website at www orajel com

#1

ORAL PAIN RELIEVER

BRAND FOR TOOTHACHE

NON-NUMBING RELIEF!

Orajel™

Analgesic & Astringent Rinse

For TOOTHACHE

Double Medicated

Provides All-Over Oral Pain Relief

Soothes Irritated Gums

Cleans Affected Area

Kills Odor-Causing Bacteria

Soothing

Mint

16 FL OZ (473.2 mL)

ORAJEL TOOTHACHE RINSE 
benzyl alcohol, zinc chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-764
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZYL ALCOHOL (BENZYL ALCOHOL) BENZYL ALCOHOL2.91 mg  in 1 mL
ZINC CHLORIDE (ZINC CATION) ZINC CATION1.62 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYL SALICYLATE 
POLOXAMER 338 
POLYSORBATE 20 
SODIUM BENZOATE 
SORBITOL 
FD&C BLUE NO. 1 
CALCIUM DISODIUM PYROPHOSPHATE 
MENTHOL 
POTASSIUM SODIUM SACCHARATE 
SODIUM PYROPHOSPHATE 
WATER 
ALCOHOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10237-764-16473.2 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/01/2016
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIOperations
Church & Dwight Co., Inc253933600manufacture(10237-764)

 
Church & Dwight Co., Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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