Orajel Antiseptic Rinse For All Mouth Sores

Orajel Antiseptic Rinse For All Mouth Sores
SPL v5
SPL
SPL Set ID 06188d36-0d60-6ae6-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2014-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-11-01

Description

Hydrogen peroxide 1.5% Menthol 0.1%


Medication Information

Warnings and Precautions

When using this productdo not swallow

do not exceed recommended dosage

Indications and 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

Aids in the removal of:

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

Description

Hydrogen peroxide 1.5% Menthol 0.1%

Section 50565-1

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

Section 50566-9

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

Section 50570-1

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

Section 51727-6

alcohol (4.1% by volume), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

Section 51945-4

#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)

Section 53413-1

Questions or comments call us at 1–800–952–5080 M–F 9am–5pm ET or visit our website at www.orajel.com

Section 55105-1

Oral debriding agent/Oral antiseptic

Oral pain reliever

Section 55106-9

Hydrogen peroxide 1.5%

Menthol 0.1%

Section 60561-8

Other Information

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

Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

When using this productdo not swallow

do not exceed recommended dosage

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

alcohol (4.1% by volume), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

Section 51945-4 (51945-4)

#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)

Section 53413-1 (53413-1)

Questions or comments call us at 1–800–952–5080 M–F 9am–5pm ET or visit our website at www.orajel.com

Section 55105-1 (55105-1)

Oral debriding agent/Oral antiseptic

Oral pain reliever

Section 55106-9 (55106-9)

Hydrogen peroxide 1.5%

Menthol 0.1%

Section 60561-8 (60561-8)

Other Information

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)