MedPath

Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity Fluoride

Brush Buddies FLAVORED Anticavity Fluoride Toothpaste

Approved
Approval ID

3436532d-e078-4dbb-a823-b4542e961534

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 16, 2025

Manufacturers
FDA

Ashtel Studios, Inc.

DUNS: 148689180

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70108-238
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateSeptember 16, 2025
FDA Product Classification

INGREDIENTS (24)

SODIUM FLUORIDEActive
Quantity: 0.243 g in 100 g
Code: 8ZYQ1474W7
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 1600Inactive
Code: 1212Z7S33A
Classification: IACT
GELIDIELLA ACEROSAInactive
Code: T91K54D6M1
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
PHTHALOCYANINE BLUEInactive
Code: 3VEX9T7UT5
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CHROMIC OXIDEInactive
Code: X5Z09SU859
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/18/2025

Packaging

MintChocChipToothpaste-2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/16/2025

Uses

• helps protect teeth and roots against cavities.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/18/2025

HELPS PREVENT CAVITIES

DESIGNED IN U.S.A.
MADE IN INDIA

WWW.BRUSHBUDDIES.COM
1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CALIFORNIA 91761

Brush 2 Minutes

2 Times Daily

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/16/2025

Active ingredient

Sodium Fluoride 0.243%
(Fluoride ion Content 1100 ppm)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/16/2025

Purpose

Anticavity

WARNINGS SECTION

LOINC: 34071-1Updated: 9/16/2025

Warnings

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/18/2025

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.
Do not** swallow.**
•** Children 2 to 6 years:** to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
** Children under 2 years of age:** Consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/18/2025

Inactive ingredients

Sorbitol, Silica, Aqua(Water), PEG-32, Agar Agar, CI 73360, CI 74160, CI 77499, CI 77492, CI 77288, Sodium Alginate, Glycerin, Phenoxyethanol, Deionized Water, Xylitol, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Benzyl Alcohol, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tri Sodium Ortho Phosphate, CI 19140, CI NO. 19140 + CI 42090

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/16/2025

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