Orajel Toothache Rinse
41709710-5392-3119-e054-00144ff88e88
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:04:33.730624 · Updated: 2026-03-14T23:05:23.931529