Orajel 4x Medicated For Toothache And Gum, Cream

Orajel 4x Medicated For Toothache And Gum, Cream
SPL v7
SPL
SPL Set ID 999aa7b9-bf9e-9285-e053-2a95a90a345b
Route
TOPICAL
Published
Effective Date 2019-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg) Benzocaine (200 mg) Menthol, Unspecified Form (2.6 mg) Zinc Cation (1.5 mg)
Inactive Ingredients
Saccharin Sodium Methyl Salicylate Polyethylene Glycol 400 Peg-75 Lanolin Peg/ppg-116/66 Copolymer Sorbic Acid Titanium Dioxide Ammonium Glycyrrhizate Poloxamer 407 Water

Identifiers & Packaging

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

Description

Benzalkonium chloride 0.13% Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%

Purpose

Oral antiseptic, Oral pain reliever, Oral astringent


Medication Information

Purpose

Oral antiseptic, Oral pain reliever, Oral astringent

Description

Benzalkonium chloride 0.13% Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%

Uses
  • 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 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 older

  • 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

Benzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Inactive Ingredients

ammonium glycyrrhizate, flavor, PEG-8, PEG-75, PEG/PPG 116/66 copolymer, poloxamer 407, sodium saccharin, sorbic acid, titanium dioxide, 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 FOR TOOTHACHES

Ready-Open Tube Tip

Orajel

4X MEDICATED FOR TOOTHACHE AND GUM

INSTANT PAIN RELIEF CREAM

Clinical Strength Pain Relief

Proven to Kill Harmful Bacteria

Helps Prevent Infection

Cooling Relief for Gum Irritation

ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT

NET WT

0.33 OZ (9.4 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

Uses
  • 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 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 older

  • 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 (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 (Active ingredients)

Benzalkonium chloride 0.13%

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Inactive Ingredients (Inactive ingredients)

ammonium glycyrrhizate, flavor, PEG-8, PEG-75, PEG/PPG 116/66 copolymer, poloxamer 407, sodium saccharin, sorbic acid, titanium dioxide, 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 FOR TOOTHACHES

Ready-Open Tube Tip

Orajel

4X MEDICATED FOR TOOTHACHE AND GUM

INSTANT PAIN RELIEF CREAM

Clinical Strength Pain Relief

Proven to Kill Harmful Bacteria

Helps Prevent Infection

Cooling Relief for Gum Irritation

ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT

NET WT

0.33 OZ (9.4 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

All Sections (JSON)