Orajel Toothache Rinse - DailyMed

ORAJEL TOOTHACHE RINSE- benzyl alcohol, zinc chloride liquid  Church & Dwight Canada Corp.

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Orajel Toothache Rinse

Benzyl Alcohol 0.27%

Zinc Chloride 0.15%

Oral pain reliever

Oral astringent

Usefor 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 usethis 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 Ingredientsalcohol (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 commentscalls 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™

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)

ORAJEL TOOTHACHE RINSE  benzyl alcohol, zinc chloride liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62864-764 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 2.7 mg  in 1 mL ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1.5 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:62864-764-16 473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2016 12/31/2023 2 NDC:62864-764-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/24/2018 12/31/2023

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 12/01/2016 12/31/2023

Labeler - Church & Dwight Canada Corp. (253933600)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Canada Corp.	253933600	manufacture(62864-764)

Revised: 11/2024 Document Id: 27d38db0-2620-ce46-e063-6394a90a7d56 34390-5 Set id: 5e20cda5-1202-3a12-e053-2991aa0aa951 Version: 4 Effective Time: 20241126  Church & Dwight Canada Corp.