ORBITOL FLUORIDE WHITENING TOOTHPASTE- sodium monofluorophosphate paste

Orbitol Fluoride Whitening Toothpaste by

Drug Labeling and Warnings

Orbitol Fluoride Whitening Toothpaste by is a Otc medication manufactured, distributed, or labeled by tropical degil cosmetics industries ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium monofluorophosphate 0.8% w/w (1000 ppm fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

WARNINGS

Do not use

Do not use if you are sensitive to any of the ingredients in this prouduct.

When using this product

When using this product avoid contact with eyes.

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 6 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
• Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Inactive ingredients

water, sorbitol, calcium carbonate, silica, peg-32, cellulose gum, sodium lauryl sulfate, sodium bicarbonate, flavor, titanium dioxide, sodium saccharin, sodium benzoate, menthyl lactate, benzoic acid, zinc citrate, limonene

Other information

Other information store below 30°C (86°F).

Principal Display Panel

INGREDIENTS AND APPEARANCE

ORBITOL FLUORIDE WHITENING TOOTHPASTE 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62685-232
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
ZINC CITRATE (UNII: K72I3DEX9B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62685-232-04	1 in 1 BOX	09/27/2021
1		145 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 final	part355	09/27/2021

Labeler - tropical degil cosmetics industries ltd (600437230)

Establishment
Name	Address	ID/FEI	Business Operations
tropical degil cosmetics industries ltd		600437230	manufacture(62685-232)