Orajel Gum Pain 3x Medicated, Gel

Orajel Gum Pain 3x Medicated, Gel
SPL v3
SPL
SPL Set ID 9a1632ad-2b47-5653-e053-2995a90ae0d9
Route
TOPICAL
Published
Effective Date 2023-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg) Zinc Cation (1.5 mg) Menthol, Unspecified Form (2.6 mg)
Inactive Ingredients
Water Polyethylene Glycol 400 Methyl Salicylate Saccharin Sodium Sorbic Acid Peg-75 Lanolin Ammonium Glycyrrhizate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-17

Description

Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%

Purpose

Oral pain reliever and Oral astringent


Medication Information

Purpose

Oral pain reliever and Oral astringent

Description

Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%

Use

for the temporary relief of pain due to minor irritation or injury of the mouth and gums

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

Active Ingredients

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Inactive Ingredients

ammonium glycyrrhizate, 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 ADULTS

Open Tube Tip

Orajel

GUM PAIN

3X MEDICATED GEL

INSTANT PAIN RELIEF

20% Benzocaine to Relieve Gum Pain

Cooling Relief to Soothe Gums

Relieves Gum Irritation

ORAL PAIN RELIEVER/ASTRINGENT

NET WT

0.125oz (3.5g)

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

Purpose

Oral pain reliever and 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

Active Ingredients (Active ingredients)

Benzocaine 20%

Menthol 0.26%

Zinc chloride 0.15%

Inactive Ingredients (Inactive ingredients)

ammonium glycyrrhizate, 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 ADULTS

Open Tube Tip

Orajel

GUM PAIN

3X MEDICATED GEL

INSTANT PAIN RELIEF

20% Benzocaine to Relieve Gum Pain

Cooling Relief to Soothe Gums

Relieves Gum Irritation

ORAL PAIN RELIEVER/ASTRINGENT

NET WT

0.125oz (3.5g)

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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