Orajel 4x Medicated For Toothache And Gum, Gel

Orajel 4x Medicated For Toothache And Gum, Gel
SPL v9
SPL
SPL Set ID 999851ac-925c-7d1f-e053-2a95a90a240b
Route
TOPICAL
Published
Effective Date 2019-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg) Menthol, Unspecified Form (5 mg) Benzalkonium (1.3 mg) Zinc Cation (1.5 mg)
Inactive Ingredients
Sorbic Acid Polyethylene Glycol 400 Peg-75 Lanolin Saccharin Sodium Water Ammonium Glycyrrhizate Fd&c Blue No. 1 Methyl Salicylate

Identifiers & Packaging

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

Description

Belzalkonium chloride 0.13% Benzocaine 20% Menthol 0.5% Zinc chloride 0.15%

Purpose

Oral antiseptic, Oral pain reliever, Oral astringent


Medication Information

Purpose

Oral antiseptic, Oral pain reliever, Oral astringent

Description

Belzalkonium chloride 0.13% Benzocaine 20% Menthol 0.5% Zinc chloride 0.15%

Use
  • for the temporary relief of pain due to minor irritation or injury of the mouth and gums
  • first aid to help prevent infection in minor oral irritation
Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Directions

Adults and children 2 years of age and over

  • Apply to affected area up to 4 times daily or as directed by a dentist or doctor

Children between 2 and 12 years of age

  • Ask a doctor before use. Should be supervised in the use of this product

Children under 2 years of age

  • Do not use

Do Not Use
  • more than directed
  • for more than 7 days unless directed by a dentist or doctor
  • for teething
  • in children under 2 years of age
Other Information
  • do not use if Tamper-Evident tab is open before first use
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Active Ingredients

Belzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.5%

Zinc chloride 0.15%

Inactive Ingredients

ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, 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

#1 ORAL PAIN RELIEVER BRAND FOR TOOTHACHE

Ready-Open Tube Tip

Orajel

4X MEDICATED FOR TOOTHACHE AND GUM GEL

INSTANT PAIN RELIEF

Clinical Strength for Pain Relief

Proven to Kill Harmful Bacteria

Helps Prevent Infection

Cooling Relief for Gum Irritation

ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT

NET WT

0.25 oz (7.0 g)

Stop Use and Ask A Doctor If
  • symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
Keep Out of Reach of Children

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away


Structured Label Content

Use
  • for the temporary relief of pain due to minor irritation or injury of the mouth and gums
  • first aid to help prevent infection in minor oral irritation
Purpose

Oral antiseptic, Oral pain reliever, Oral astringent

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Directions

Adults and children 2 years of age and over

  • Apply to affected area up to 4 times daily or as directed by a dentist or doctor

Children between 2 and 12 years of age

  • Ask a doctor before use. Should be supervised in the use of this product

Children under 2 years of age

  • Do not use

Do Not Use (Do not use)
  • more than directed
  • for more than 7 days unless directed by a dentist or doctor
  • for teething
  • in children under 2 years of age
Other Information
  • do not use if Tamper-Evident tab is open before first use
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Active Ingredients

Belzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.5%

Zinc chloride 0.15%

Inactive Ingredients

ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, 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 TOOTHACHE

Ready-Open Tube Tip

Orajel

4X MEDICATED FOR TOOTHACHE AND GUM GEL

INSTANT PAIN RELIEF

Clinical Strength for Pain Relief

Proven to Kill Harmful Bacteria

Helps Prevent Infection

Cooling Relief for Gum Irritation

ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT

NET WT

0.25 oz (7.0 g)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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