Active Ingredient
Benzocaine 7.5%
Makesense
FDA Label NDC 69020-206
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cherry Hill Sales Co for the product Makesense (NDC 69020-206). 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 dentist or doctor 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 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
Image Description (Oralgeljrlbl)
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