CAREKON ANTI-CAVITY FLUORIDE- sodium monofluorophosphate paste

CAREKON ANTI-CAVITY FLUORIDE by

Drug Labeling and Warnings

CAREKON ANTI-CAVITY FLUORIDE by is a Otc medication manufactured, distributed, or labeled by Hunan Yinhuatang Pharmaceutical Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium monofluorophosphate 0.76% (0.76g/100g)

PURPOSE

Anticavity

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age

INDICATIONS & USAGE

Adults and children 2 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 doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

WARNINGS

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults and children 2 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 doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

INACTIVE INGREDIENT

Sorbitol, Water, Hydrated Silica, Dicalcium Phosphate, Hydroxyapatite, Glycerin, Cocamidopropyl Betaine, Sodium Lauroyl Sarcosinate, Fragrance, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Tetrasodium Pyrophosphate, Titanium Dioxide, Sodium Saccharin, Citric Acid, Beta-Glucan

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREKON ANTI-CAVITY FLUORIDE 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84345-086
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  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TETRASODIUM PYROPHOSPHATE (UNII: O352864B8Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
FRAGRANCE 13576 (UNII: 5EM498GW35)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYAPATITE (UNII: 91D9GV0Z28)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
1,3-BETA-GLUCAN SYNTHASE COMPONENT FKS1 (UNII: 4FRY3LJG0V)
CELLULOSE GUM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
DICALCIUM PHOSPHATE (UNII: L11K75P92J)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84345-086-01	1 in 1 BOX	08/06/2025
1		100 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	08/06/2025

Labeler - Hunan Yinhuatang Pharmaceutical Technology Co., Ltd. (700229500)

Establishment
Name	Address	ID/FEI	Business Operations
Hunan Yinhuatang Pharmaceutical Technology Co., Ltd.		700229500	manufacture(84345-086) , label(84345-086)