Active Ingredients
Hydrogen peroxide 1.5%
Menthol 0.1%
Orajel Antiseptic Alcohol-free Mouth Sore Rinse Liquid
FDA Label NDC 10237-784
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Orajel Antiseptic Alcohol-free Mouth Sore Rinse (NDC 10237-784). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, stop use, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral debriding agent/Oral antiseptic, Oral pain reliever
Uses
- first aid to help reduce bacteria in minor oral wounds
- for temporary pain relief and
- use in cleansing minor wounds or minor gum inflammation resulting from:
- minor dental procedures
- orthodontic appliances
- dentures
- accidental injury
- canker sores
- other irritations of the mouth and gums
- phlegm
- mucus
- other secretions associated with occasional sore mouth
Aids in the removal of:
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
Stop Use and see your physician promptly if
- swelling, rash or fever develops
- irritations, pain or redness persists or worsens
- sore mouth symptoms do not improve in 7 days
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
Adults and children 2 years of age and older
- Swish one-half capful (2 tesapoons=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
- Should be supervised in the use of this product
- Consult a dentist or healthcare provider
Children under 12 years of age
Children under 2 years of age
Other Information
- cap tightly
- keep away from heat or direct sunlight
- do not use if safety seal is broken or missing
Inactive Ingredients
blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water
Questions Or Comments?
Questions or comments call us at 1–800–952–5080 M–F 9am–5pm ET or visit our website at www.orajel.com
Principal Display Panel
#1 ORAL PAIN RELIEVER BRAND FOR ADULTS
With PAIN RELIEF!
Orajel
ALCOHOL FREE
FOR ALL MOUTH SORES
ANTISEPTIC RINSE
Canker Sores Cheek Bites Gum Irritation Irritation from Dentures or Braces
Promotes Healing
Kills Bacteria
Provides Pain Relief
SOOTHING MINT RINSE
16 FL OZ (473.2 mL)
ORAL DEBRIDING AGENT/ANTISEPTIC RINSE/PAIN RELIEVER
Da2011185_ojlbf-00003-03_72013523 (Da2011185 Ojlbf 00003 03 72013523)
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