Active Ingredient
Sodium Monofluorophosphate 0.76%
Sparklefresh Paste, Dentifrice
FDA Label NDC 53329-083
8 label sections · Submitted to the FDA by Medline Industries, Lp · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Sparklefresh (NDC 53329-083). 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, use, warnings, keep out of reach of children under 6 years of age., directions, inactive ingredients, manufacturing information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity toothpaste
Use
aids in the prevention of dental cavities
Warnings
Keep Out Of Reach Of Children Under 6 Years Of Age.
If you accidentally swallow more than used for brushing, seek medical help or contact a Poison Center immediately.
Directions
- adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician
- instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using without supervision
- children under 2 years of age: consult a dentist or physician
Inactive Ingredients
calcium carbonate, treated water, sorbitol, precipitated silica, sodium lauryl sulfate, flavor, sodium carboxymethyl cellulose, sodium silicate, tetrasodium pyrophosphate, sodium saccharin, methylparaben, titanium dioxide, polyethylene glycol 400, propylparaben
Manufacturing Information
Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in India
www.medline.com
1-800-MEDLINE (633-5463)
REF: NONTP15I
RH22NWI
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