KIDS PRIME PEDIATRIC DENTAL GROUP ANTICAVITY FOR KIDS- sodium fluoride ointment

Kids Prime Pediatric Dental Group Anticavity for Kids by

Drug Labeling and Warnings

Kids Prime Pediatric Dental Group Anticavity for Kids 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%

Purpose

Anticavity

Use

helps protect against cavities

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.

Directions

• 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.
• Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• Children under 2 years: Ask a dentist or physician

Inactive ingredients

Sorbitol, Aqua, Hydrated Silica, PEG-300, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Carrageenan, Saccharin Sodium, Sodium Pyrophosphate, FD&C Blue No.1.

Other information

Store in a cool place, below 86°F, away from heat
Do not use if quality seal is broken or missing
Do not use after the expiration date

Package Labeling: 25g

Package Labeling: 50g

INGREDIENTS AND APPEARANCE

KIDS PRIME PEDIATRIC DENTAL GROUP ANTICAVITY FOR KIDS 
sodium fluoride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87053-008
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)
POLYETHYLENE GLYCOL 14000 (UNII: 77HY82S0LG)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87053-008-00	1 in 1 BOX	08/31/2025
1		25 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 87053-008-01	1 in 1 BOX	08/31/2025
2		50 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)