Orajel 2x Gum Pain Rinse
FDA Label NDC 10237-799

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 2x Gum Pain (NDC 10237-799). 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 other, otc - purpose, uses, otc - do not use, otc - when using, stop use and see your physician promptly if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

  • ✓Soothes & Cools Gums
  • ✓Kills Harmful Bacteria
  • ✓Promotes Healing
  • ✓Relieves Gum Irritation
    Caused by Dentures or Braces

    • ORAL DEBRIDING AGENT/
    ANTISEPTIC RINSE/PAIN RELIEVER

    Soothing
    MINT

    16 FL OZ (473.2 mL)

    OJLBF-01904-01 72025286

    Principal Display Panel (473.2 mL Bottle Label)

    Principal Display Panel (473.2 mL Bottle Label)

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