Active ingredient

Sodium Monofluorophosphate 0.76%

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

Package Label

Label RH22NWI

SPARKLEFRESH FLOURIDE TOOTHPASTE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-083
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM SILICATE (UNII: IJF18F77L3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53329-083-21	42.5 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2019
2	NDC:53329-083-92	17 g in 1 PACKET; Type 0: Not a Combination Product	08/01/2019
3	NDC:53329-083-93	24 g in 1 PACKET; Type 0: Not a Combination Product	08/01/2019
4	NDC:53329-083-94	78 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/01/2007

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

083 SparkleFresh Fluoride Toothpaste