PRIME TOOTH CARE SUMMER WATERMELON- sodium fluoride ointment

Prime Tooth Care Summer Watermelon by

Drug Labeling and Warnings

Prime Tooth Care Summer Watermelon by is a Otc medication manufactured, distributed, or labeled by Prime Tooth Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Sodium fluoride 0.25% (1100PPM) 

Purpose

Anticavity

Use

helps protect against cavities

Warnings

When using this product

• Do not swallow
• Do not use in eye area

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.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use 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.

Inactive Ingredients

Sorbitol, Aqua, Hydrated Silica, Glycerin, Sodium Lauroyl Sarcosinate, Fragrance/ Flavor, Nano-Hydroxyapatite, Xanthan Gum, Menthol, Sodium Benzoate, Carboxymethyl Cellulose, Sodium Saccharin, Xylitol, Sodium Pyrophosphate, Red Dates Extract, Ginseng Extract, Hydrogen Peroxide (PVP - H202).

Package Labeling:

INGREDIENTS AND APPEARANCE

PRIME TOOTH CARE SUMMER WATERMELON 
sodium fluoride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87053-007
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
ASIAN GINSENG (UNII: CUQ3A77YXI)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87053-007-00	1 in 1 BOX	08/31/2025
1		65 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	08/31/2025

Labeler - Prime Tooth Care LLC (119575114)

Registrant - Prime Tooth Care LLC (119575114)