KIDS KARE- sodium fluoride paste, dentifrice

Kids Kare by

Drug Labeling and Warnings

Kids Kare by is a Otc medication manufactured, distributed, or labeled by DEN-MAT HOLDINGS, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium Fluoride 0.24% (0.14% w/v fluoride ion)

Purpose

Anticavity toothpaste

Uses

Aids in the prevention of dental cavities.

Warnings

KEEP OUT OF REACH OF CHILDREN

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 or older: Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor.
• Children under 2 years of age: Consult a dentist or doctor.
• Do not swallow.
• To minimize swallowing, use a pea-sized amount in children under 6.
• Instruct children under 6 years of age in good brushing and rinsing habits.
• Supervise children as necessary until capable of using without supervision.

Other information

Do not use if the foil seal under the cap is torn, cut or missing.

Inactive ingredients

Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue 1

Questions or comments?

Call 1-800-752-2564

Principal Display Panel

kids kare™

Preventative

Treatment

0.24% Sodium Fluoride

Toothpaste

Berry Flavor

IMPORTANT:

Read directions carefully

Net Wt. 4 oz. (113.4 g)

INGREDIENTS AND APPEARANCE

KIDS KARE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59883-718
Route of Administration	DENTAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
SORBITOL (UNII: 506T60A25R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
BERRY (UNII: FV3431923Z)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59883-718-04	113.4 g in 1 TUBE; Type 0: Not a Combination Product	10/26/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/26/2017

Labeler - DEN-MAT HOLDINGS, LLC. (809857704)