Drug Facts
Composition & Profile
Identifiers & Packaging
NDC 41250- 061-19 *Compare to the active ingredient in Orajel™ 4X Medicated For Toothache & Gum Gel 4X MEDICATED toothache & gum pain relief gel Immediate Pain Relief 20% Benzocaine to Relieve Oral Pain Antiseptic to Kill Harmful Batceria Astringent to Help Prevent Infection Menthol to cool Gum & Relieves Irritation Carton R2
- NDC 41250- 061-19 *Compare to the active ingredient in Orajel™ 4X Medicated For Toothache & Gum Gel 4X MEDICATED toothache & gum pain relief gel Immediate Pain Relief 20% Benzocaine to Relieve Oral Pain Antiseptic to Kill Harmful Batceria Astringent to Help Prevent Infection Menthol to cool Gum & Relieves Irritation Carton R2
Overview
Directions Directions •cut open tip of tube on score mark • adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by children under 12 years of age should be supervised in the use of this product • children under a dentist or doctor • 2 years of age: do not use
Indications & Usage
Directions Directions •cut open tip of tube on score mark • adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by children under 12 years of age should be supervised in the use of this product • children under a dentist or doctor • 2 years of age: do not use
Dosage & Administration
Other Information Other information • do not use if tip is cut prior to opening • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted • do not use continuously • this formula will stay in place for extended duration of relief • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Warnings & Precautions
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 • more than directed • for more than 7 days unless told to do so by a dentist or doctor • for teething • in children under 2 years of age Stop use and ask a doctor if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose
Use for the temporary relief of pain due to toothaches to help protect against infection of minor oral irritation
Do Not Use
• more than directed • for more than 7 days unless told to do so by a dentist or doctor • for teething • in children under 2 years of age
Stop Use & Ask a Doctor
Stop use and ask a doctor if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs
Keep Out of Reach of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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