FLUORIDE ANTICAVITY,TOOTHPASTE- fluoride anticavity toothpaste paste, dentifrice

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium monofluorophosphate

KEEP OUT OF REACH OF CHILDREN

keep out of reach of child

PURPOSE

Protect teeth, maintain oral hygiene

INDICATIONS & USAGE

It is recommended to brush your teeth after each meal or at least twice a day.

WARNINGS

keep out of reach child

INACTIVE INGREDIENT

WATER,SORBITOL,HYDRATED SILICA,GLYCERIN,PEG-32,SODIUM LAURYL SULFATE,CELLULOSE GUM,SODIUM SACCHARIN,EUCALYPTUS GLOBULUS LEAF OIL,METHYL SALICYLATE,THYMOL,PHOSPHORIC ACID,MENTHOLUM,Tetrasodium Pyrophosphate,XANTHAN GUM,SODIUM BENZOATE,Fragrance,Spearmint Leaf Oil,Disodium Hydrogen Phosphate,CARBON BLACK,IRON OXIDES

DOSAGE & ADMINISTRATION

It is recommended to brush your teeth after each meal or at least twice a day.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLUORIDE ANTICAVITY,TOOTHPASTE 
fluoride anticavity toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87576-332
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g

Inactive Ingredients
Ingredient Name	Strength
PEG-32 (UNII: 1212Z7S33A)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
THYMOL (UNII: 3J50XA376E)
MENTHOL (UNII: L7T10EIP3A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CELLULOSE GUM (UNII: K679OBS311)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
CARBON BLACK (UNII: 4XYU5U00C4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL SALICYLATE (UNII: LAV5U5022Y)
XANTHAN GUM (UNII: TTV12P4NEE)
PHOSPHORIC ACID P-32 (UNII: N9H3ZTX0BG)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
FRAGRANCE 13576 (UNII: 5EM498GW35)
TETRASODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SPEARMINT OIL (UNII: C3M81465G5)
DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87576-332-02	1 in 1 BOX	04/03/2026
1		1 in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/03/2026

Labeler - Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd (976381745)

Registrant - Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd (976381745)

Establishment
Name	Address	ID/FEI	Business Operations
Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd		976381745	manufacture(87576-332) , label(87576-332)