MedPath

Gum Detoxify

5820068 Meijer Gum Detoxify

Approved
Approval ID

0338495b-08a5-047f-e063-6394a90aa124

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Meijer, Inc.

DUNS: 006959555

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 Code79481-0121
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 (12)

SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
ZINC CITRATEInactive
Code: K72I3DEX9B
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
STANNOUS FLUORIDEActive
Quantity: 0.14 g in 100 g
Code: 3FTR44B32Q
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/30/2023

Principal Display Panel

Carton R1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/30/2023

Uses

aids in the prevention of cavities * helps prevent gingivitis * helps interfere with teh harmful effects of plaque associated with gingivitis * helps control plaque bacteria that contribute to teh development of gingivitis

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/30/2023

Active ingredient

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/30/2023

Purpose

Anticavity/Antigingivitis

WARNINGS SECTION

LOINC: 34071-1Updated: 11/30/2023

Warnings

Keep out of reach of children under 12 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 11/30/2023

Keep out of reach of children under 12 years of age

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/30/2023

Directions

adults and children 12 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician * do not swallow * children under 12 years of age: ask a dentist

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 11/30/2023

Other information

products containing stannous fluoride may produce surface staining of the teeth * adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist * this product is specifically formulated to help prevent staining * see your dentist regularly

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/30/2023

Inactive ingredients

water, hydrated silica, sorbitol, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, zinc citrate, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

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Gum Detoxify - FDA Drug Approval Details