Otc - Active Ingredient
Hydrogen peroxide 1.5%
Menthol 0.1%
Orajel Antiseptic Rinse For All Mouth Sores Liquid
FDA Label NDC 10237-760
12 label sections · Submitted to the FDA by Church & Dwight Co., Inc. · 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 Rinse For All Mouth Sores (NDC 10237-760). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Oral debriding agent/Oral antiseptic
Oral pain reliever
Indications & Usage
- 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
- accidental injury
- orthodontic appliances
- canker sores
- dentures
- other irritations of the mouth and gums
- phlegm
- mucus
- other secretions associated with occasional sore mouth
Aids in the removal of:
Warnings
When using this productdo not swallow
do not exceed recommended dosage
Otc - Do Not Use
Do not usethis product for more than 7 days unless directed by a dentist or healthcare provider
Otc - Stop Use
Stop use and see your physician promptly ifswallowing, rash or fever develops; irritation, pain or redness persists or worsens; sore mouth symptoms do not improve in 7 days
Otc - Keep Out Of Reach Of Children
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
Dosage & 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 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 | ||
| 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 Safety Information
Other Information
- cap tightly
- keep away from heat or direct sunlight
- do not use if safety seal is broken or missing
Inactive Ingredient
alcohol (4.1% by volume), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water
Otc - Questions
Questions or commentscall us at 1–800–952–5080 M–F 9am–5pm ET or visit our website atwww.orajel.com
Package Label.Principal Display Panel
#1
ORAL PAIN
RELIEVER BRAND
FOR ADULTS
With
PAIN RELIEF!
Orajel™
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
ORAL DEBRIDING AGENT / ANTISEPTIC RINSE / PAIN RELIEVER
16 FL OZ (473.2 mL)
Da2011184_ojlbf-32499-06_72013522 (Da2011184 Ojlbf 32499 06 72013522)
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