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Equate Pro-Advanced TP

5820078 Walmart Equate Pro-Advanced (80-15078)

Approved
Approval ID

1e6561fb-4e3b-40ba-e063-6294a90a2690

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Walmart Inc.

DUNS: 051957769

Products 1

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

Stannous Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code79903-281
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Stannous Fluoride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (17)

SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ZINC LACTATEInactive
Code: 2GXR25858Y
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STANNOUS FLUORIDEActive
Quantity: 0.16 g in 100 g
Code: 3FTR44B32Q
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM POLYMETAPHOSPHATEInactive
Code: P1BM4ZH95L
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM GLUCONATEInactive
Code: R6Q3791S76
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/18/2024

![2821079R1](/dailymed/image.cfm?name=2821078R1+Equate+Pro- Advanced.jpg&id=892203)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/18/2024

aids in the prevention of cavities

helps prevent gingivitis

helps interfere with the harmful effects of plaque associated with gingivitis

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/18/2024

Stannous fluoride 0.454% (0.16% w/v fluoride ion)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/18/2024

glycerin, hydrated silica, sodium hexametaphosphate, water, propylene glycol, PEG-8, zinc lactate, flavor, sodium lauryl sulfate, sodium gluconate, sodium saccharin, trisodium phosphate, xanthan gum, PVP, carrageenan, cocamidopropyl betaine, blue 1

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/18/2024

Anticavity, antigingivitis, antisensitivity

WARNINGS SECTION

LOINC: 34071-1Updated: 12/18/2024

when using this product, if irritation occurs discontinue use.

Stop use and ask a dentist if if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivty still persists after 4 weeks of use.

Keep out of reach or children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/18/2024

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get meedical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/18/2024

Directions adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush • brush teeth thoroughly for at least one minute twice a day (morning and evening) or as recommended by a dentist.

Make sure to brush all sensitive areas of the teeth. Do not swallow. • children under 12 years of age: Consult a dentist

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Equate Pro-Advanced TP - FDA Drug Approval Details