Active Ingredients
Benzalkonium chloride 0.13%
Benzocaine 20%
Menthol 0.26%
Zinc chloride 0.15%
Orajel 4x Medicated For Toothache And Gum, Cream
FDA Label NDC 10237-788
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Orajel 4x Medicated For Toothache And Gum, Cream (NDC 10237-788). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral antiseptic, Oral pain reliever, Oral astringent
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
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
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
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
- Ask a doctor before use. Should be supervised in the use of this product
- Do not use
Children between 2 and 12 years of age
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
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)
Da2009001_ojfc-32501-10_72013318 (Da2009001 Ojfc 32501 10 72013318)
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