GUM DETOXIFY- stannous fluoride paste, dentifrice

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

PURPOSE

Anticavity/Antigingivitis

INDICATIONS & USAGE

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

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.

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

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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUM DETOXIFY 
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-174
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ZINC CITRATE (UNII: K72I3DEX9B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XANTHAN GUM (UNII: TTV12P4NEE)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-174-10	1 in 1 CARTON	04/20/2026
1		116 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	04/20/2026

Labeler - Walmart (051957769)

Registrant - Lornamead products (119559733)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Products		119559733	manufacture(49035-174) , pack(49035-174)