Orajel Antiseptic Alcohol-free Mouth Sore Rinse

Orajel Antiseptic Alcohol-free Mouth Sore Rinse
SPL v6
SPL
SPL Set ID 99d47d6a-fa2e-d5ee-e053-2995a90aa11d
Route
ORAL
Published
Effective Date 2019-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (1 mg) Hydrogen Peroxide (15 mg)
Inactive Ingredients
Sorbitol Water Saccharin Sodium Edetate Disodium Propylene Glycol Fd&c Blue No. 1 Methyl Salicylate Phosphoric Acid Poloxamer 338 Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-01

Description

Hydrogen peroxide 1.5% Menthol 0.1%

Purpose

Oral debriding agent/Oral antiseptic, Oral pain reliever


Medication Information

Purpose

Oral debriding agent/Oral antiseptic, Oral pain reliever

Description

Hydrogen peroxide 1.5% Menthol 0.1%

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

Aids in the removal of:

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

Do not usethis 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

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

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 Information
  • cap tightly
  • keep away from heat or direct sunlight
  • do not use if safety seal is broken or missing
Active Ingredients

Hydrogen peroxide 1.5%

Menthol 0.1%

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

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


Structured Label Content

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

Aids in the removal of:

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

Oral debriding agent/Oral antiseptic, Oral pain reliever

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
Warnings

Do not usethis 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

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

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 Information (Other information)
  • cap tightly
  • keep away from heat or direct sunlight
  • do not use if safety seal is broken or missing
Active Ingredients (Active ingredients)

Hydrogen peroxide 1.5%

Menthol 0.1%

Inactive Ingredients (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?)

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

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


Advanced Ingredient Data


Raw Label Data

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