Orajel Kids Superman

Description

DC Studios Superman Stage 3 toothpaste is designed for children aged 2 to 10 years. This anti-cavity formulation contains fluoride to help protect against tooth decay. The toothpaste features a natural watermelon flavor, making it appealing for young users. It is presented in a net weight of 4.2 ounces (119 grams).

Uses and Indications

This drug is indicated for the prevention of dental decay. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Twist off the cap and remove the foil seal prior to use. The product is intended for oral use only and should not be swallowed.

For adults and children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist or physician. Children under 6 years of age should be instructed in proper brushing and rinsing techniques to minimize the risk of swallowing the product.

For children under 2 years, consultation with a dentist or physician is advised before use. It is important to supervise children as necessary until they are capable of using the product without supervision.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion and potential harm.

In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

This warning highlights the importance of proper usage and supervision to prevent accidental ingestion, which could lead to serious health consequences.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Orajel Kids Superman (anticavity toothpaste). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

Supervision is necessary for children until they are capable of using the product without assistance. For children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or to use the product as directed by a dentist or physician.

For children under 6 years, caregivers should instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. For children under 2 years, consultation with a dentist or physician is recommended prior to use.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for Orajel Kids Superman anticavity toothpaste gel. Therefore, the effects on lactating mothers and breastfed infants are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for overdosage treatment, which may involve symptomatic management and, if indicated, decontamination measures.

In all cases of suspected overdosage, timely communication with poison control and adherence to local guidelines for emergency care are paramount to ensure patient safety and effective management.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing the risk of adverse effects.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is not exposed to freezing conditions. To maintain product integrity, the cap must be kept tightly closed when the product is not in use. Additionally, any unused portion of the product should be discarded after opening, adhering to the recommended timeframe for safe usage, although this specific timeframe is not detailed in the provided information.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is necessary.

Patients should be instructed to twist off the cap and remove the foil seal before use, and to avoid swallowing the product. Supervision of children is recommended until they are capable of using the product without assistance. Additionally, caregivers should teach children under 6 years about proper brushing and rinsing techniques to minimize swallowing. For children under 2 years, consultation with a dentist or physician is advised.

Drug Information (PDF)

This file contains official product information for Orajel Kids Superman, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)