Active Ingredient
Benzocaine 7.5%
My Fair Baby
FDA Label NDC 20276-560
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Delta Brands Inc for the product My Fair Baby (NDC 20276-560). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a physician if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Pain Reliever
Uses
for the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.
Warnings
Allergy alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics
Do Not Use
■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider
When Using This Product
■ fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician
Stop Use And Ask A Physician If
sore mouth symptoms do not get better in 7 days ■ irritation, pain or redness does not go away ■ swelling, rash or fever develops
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
■ wash your hands ■ use your fingertip or cotton applicator to apply a small pea-size amount of Oral Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a physician or healthcare provider ■ for children under 2 years of age, consult a physician or health care provider
Other Information
do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening
Inactive Ingredients
cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin
Package Label
Image Description (Bbyoralgellbl)
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