Orajel Gum Pain 3X Medicated, Gel
Orajel 3X Medicated For Toothache and Gum by
Drug Labeling and Warnings
Orajel 3X Medicated For Toothache and Gum by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
ORAJEL GUM PAIN 3X MEDICATED- benzocaine, menthol, zinc chloride gel
Church & Dwight Co., Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Orajel Gum Pain 3X Medicated, Gel
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
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
Inactive ingredients
ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water
| ORAJEL GUM PAIN 3X MEDICATED
benzocaine, menthol, zinc chloride gel |
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| Labeler - Church & Dwight Co., Inc. (001211952) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Church & Dwight Co., Inc. | 043690812 | manufacture(10237-791) | |