Orajel Toothache Rinse

Orajel Toothache Rinse
SPL v8
SPL
SPL Set ID 41709710-5392-3119-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzyl Alcohol (2.7 mg) Zinc Cation (1.5 mg)
Inactive Ingredients
Methyl Salicylate Poloxamer 338 Polysorbate 20 Sodium Benzoate Sorbitol Fd&c Blue No. 1 Calcium Disodium Pyrophosphate Menthol, Unspecified Form Potassium Sodium Saccharate Sodium Pyrophosphate Water Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-01

Description

Benzyl Alcohol 0.27% Zinc Chloride 0.15%


Medication Information

Warnings and Precautions

Warnings

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

Indications and Usage

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

Dosage and 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

Description

Benzyl Alcohol 0.27% Zinc Chloride 0.15%

Section 50565-1

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

Section 50566-9

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.

Section 50567-7

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

Section 51727-6

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

Section 51945-4

#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)

Section 53413-1

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

Section 55105-1

Oral pain reliever

Oral astringent

Section 55106-9

Benzyl Alcohol 0.27%

Zinc Chloride 0.15%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

#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)

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Oral pain reliever

Oral astringent

Section 55106-9 (55106-9)

Benzyl Alcohol 0.27%

Zinc Chloride 0.15%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)