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  5. Label Information: Orajel 2x Gum Pain Alcohol-free

FDA Label for Orajel 2x Gum Pain Alcohol-free

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. OTC - WHEN USING
    6. STOP USE AND SEE YOUR PHYSICIAN PROMPTLY IF
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?
    12. PRINCIPAL DISPLAY PANEL - 473.2 ML BOTTLE LABEL

Orajel 2x Gum Pain Alcohol-free 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.

Other



Drug Facts


Otc - Purpose



Active ingredientsPurpose
Hydrogen peroxide 1.5%Oral debriding agent/Oral antiseptic
Menthol 0.1%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
    • accidental injury
    • orthodontic appliances
    • canker sores
    • dentures
    • other irritations of the mouth and gums

      • Aids in the removal of:

      • phlegm
      • mucus
      • other secretions associated with occasional sore mouth

Otc - Do Not Use



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


Otc - When Using



When using this product do not swallow

  • do not exceed recommended dosage

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

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


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 olderSwish 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 ageShould be supervised in the use of this product
    Children under 2 years of ageConsult 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

Inactive Ingredients



disodium EDTA, FD&C blue no.1, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water


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 - 473.2 Ml Bottle Label



1#
ORAL PAIN
RELIEF BRAND
FOR ADULTS

Orajel™
2X
GUM PAIN RINSE
MEDICATED
ALCOHOL FREE

EFFECTIVE ORAL PAIN RELIEF

* Please review the disclaimer below.