FIREFLY SMILEGUARD KIDS- sodium monofluorophosphate paste
Dr. Fresh, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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FireFly SmileGuard Kids Kit

Active Ingredient

Sodium monofluorphosphate 0.76%

Purpose

Anticavity toothpaste

Uses

Helps prevent against cavities

Warnings

If more than used for brushing is accidentally swallowed, medical help or contact a poison control center immediately.

Keep out of the reach of children under 6 years of age.

Directions

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Do not swallow. To minimize swallowing use a pea-sized amount for children under 6. Supervise children's brushing until good habits are established.

Children under 2 years: Ask a dentist or physician

Inactive Ingredients

Sorbitol, Water, hydrated silica, trisodium phosphate, sodium lauryl sulfate, sodium phosphate, xanthan gum, flavor, sodium saccharin, carbomer 956, mica, titanium dioxide, Blue 1

Comments? Questions?

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USA - Dr. Fresh, Inc.
Buena Park, CA 90620 USA

Canada - Dr. Fresh, Inc.
Ontario, Canada L7C2T4

U.K. Grosvenor Consumer
Products Limited
25 Gore Road, Burnham, Bucks SL18AB

FIREFLY SMILEGUARD KIDS
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64893-613
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
MICA (UNII: V8A1AW0880)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN (UNII: FST467XS7D)
PHOSPHATE ION (UNII: NK08V8K8HR)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64893-613-01	1 in 1 PACKAGE	06/21/2011	01/01/2015
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/21/2011	01/01/2015

Labeler - Dr. Fresh, LLC (117376803)

Revised: 9/2021

Document Id: 910bfb87-c780-4146-9732-64e79cbad086

Set id: 61869a81-3900-4e4e-af8a-758ca7dfaf19

Version: 4

Effective Time: 20210927

Dr. Fresh, LLC