ORAJEL TOOTHACHE RINSE- benzyl alcohol, zinc chloride liquid

Orajel Toothache Rinse by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Benzyl Alcohol 0.27%

Zinc Chloride 0.15%

PURPOSE

Oral pain reliever

Oral astringent

INDICATIONS & USAGE

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

Warnings

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

WHEN USING

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

STOP USE

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

#1

ORAL PAIN RELIEVER

BRAND FOR TOOTHACHE

NON-NUMBING RELIEF!

Orajel™

For TOOTHACHE

Analgesic & Astringent Rinse

Provides All-Over Oral Pain Relief

Soothes Irritated Gums

Cleans Affected Area

Kills Odor-Causing Bacteria

Soothing

Mint

Rinse

ORAL PAIN RELIEVER/

ASTRINGENT

16 FL OZ (473.2 mL)

INGREDIENTS AND APPEARANCE

ORAJEL TOOTHACHE RINSE 
benzyl alcohol, zinc chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-764
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH)	BENZYL ALCOHOL	2.91 mg  in 1 mL
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLOXAMER 338 (UNII: F75JV2T505)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CALCIUM DISODIUM PYROPHOSPHATE (UNII: T9L63LWS5A)
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-764-16	473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/01/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc		253933600	manufacture(10237-764)