FDA Label for Orajel Antiseptic Alcohol-free Mouth Sore Rinse
View Indications, Usage & Precautions
Orajel Antiseptic Alcohol-free Mouth Sore Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Church & Dwight Co., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Hydrogen peroxide 1.5%
Menthol 0.1%
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
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