Baby Orajel

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

No information is available on the relationship of age to the effects of benzocaine lozenges in the pediatric population. Safety and efficacy have not been established in children below 5 years of age.

Geriatric

No information is available on the relationship of age to the effects of benzocaine in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection in or around your mouth or
• Large sores in or around your mouth—The chance of side effects may be increased.

Applies to benzocaine topical: compounding powder, mucous membrane gel, mucous membrane liquid, mucous membrane lozenge, mucous membrane paste, mucous membrane powder for reconstitution, mucous membrane spray, mucous membrane swab, mucous membrane tablet disintegrating, rectal ointment, rectal suppository, topical cream, topical gel, topical liquid, topical lotion, topical ointment, topical spray, topical stick, topical swab

Dermatologic

Dermatologic side effects have included contact dermatitis and urticaria.[Ref]

Local

Local side effects have included burning and stinging.[Ref]

Other

Other side effects have included edema.[Ref]

Cardiovascular

Cardiovascular side effects have included angioedema.

Hematologic

Hematologic side effects have included methemoglobinemia. FDA continues to receive reports of methemoglobinemia from postmarketing reporting.[Ref]

Some side effects of Orajel Baby may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.