ORTHOCARE- sodium fluoride paste, dentifrice

Orthocare by

Drug Labeling and Warnings

Orthocare by is a Otc medication manufactured, distributed, or labeled by Orthosciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive Ingredient

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental 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.

Other Information:

For your protection, this tube has a foil seal under the cap.

Directions

• Adults and children 2 years of age and older: Use a pea sized amount and 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's brushing until good habits are established.
• Children under 2 years: Consult a dentist or doctor.

Inactive Ingredients

Sorbitol, Hydrated Silica, Water, Glycerin, PEG-12, Lysine, Arginine, Sodium Lauryl Sulfate, Titanium Dioxide, Flavor, Cellulose Gum, Alanine, Sodium Benzoate, Disodium Phospate, Sodium Saccharin, FD&C Blue #1

Questions?

1-833-261-0246

Principal Display

OrthoSciences™

ORTHOCARE

Specially formulated for those with braces

NET WT. 4.4 OZ. (125 grams) Anticavity Fluoride Toothpaste

INGREDIENTS AND APPEARANCE

ORTHOCARE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73051-0754
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
ALANINE (UNII: OF5P57N2ZX)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MINT (UNII: FV98Z8GITP)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ARGININE (UNII: 94ZLA3W45F)
LYSINE (UNII: K3Z4F929H6)
SODIUM LAURYL PHOSPHATE (UNII: 9ECT856LYU)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73051-0754-1	125 g in 1 TUBE; Type 0: Not a Combination Product	04/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/17/2019

Labeler - Orthosciences, Inc. (044448056)