FDA Label for My Fair Baby Oral Gel Instant Pain Relief
View Indications, Usage & Precautions
My Fair Baby Oral Gel Instant Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Anicare Pharmaceuticals Pvt. Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Benzocaine 7.5%
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
* Please review the disclaimer below.