FDA Label for Makesense Junior Pain Relief

View Indications, Usage & Precautions

Makesense Junior Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Cherry Hill Sales Co. 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 Dentist Or Doctor 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 immediately.


Directions



■ wash hands ■ cut open tip of tube on score mark ■ use your fingertip or cotton applicator to apply a small pea-size amount of MakeSense Junior Teething Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a dentist or physician ■ for infants under 2 years of age, ask a doctor or health care provider


Other Information



■ store at 59 to 77F (15-25C) ■ do not use if tube tip is cut prior to opening


Inactive Ingredients



Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben


Package Label




* Please review the disclaimer below.