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Equate Optimal Care TP

5820077 Walmart Equate Optimal Care (80-15077)

Approved
Approval ID

1e65b83e-a51a-4adb-e063-6394a90a06b4

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 Code79903-280
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 (19)

PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STANNOUS FLUORIDEActive
Quantity: 0.16 g in 100 g
Code: 3FTR44B32Q
Classification: ACTIM
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
POLYETHYLENE GLYCOL 12000Inactive
Code: VM53EE110J
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM PYROPHOSPHATEInactive
Code: O352864B8Z
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ZINC LACTATEInactive
Code: 2GXR25858Y
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

2821077R1

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% (0.15% w/v fluoride ion)

INACTIVE INGREDIENT SECTION

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

water, hydrated silica, sorbitol, glycerin, PEG-12, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, sodium citrate, zinc lactate, cellulose gum, sodium saccharin, cocamidopropyl betaine, propylene glycol, xanthan gum, citric acid, sucralose, titanium dioxide, sodium hydroxide

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 • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use.

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 medical 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 Optimal Care TP - FDA Drug Approval Details