DENTAL PLUS WHITENING- sodium monofluorophosphate paste

Dental Plus Whitening by

Drug Labeling and Warnings

Dental Plus Whitening 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% (1,000 ppm F)

Purpose

anticavity

Use

Aids in the prevention of dental cavities

WARNINGS

Ask a dentist before use if you have

bleeding or redness lasting more than 2 weeks, pain, swelling, pus, loose teeth, or more spacing between teeth. These may be signs of periodontitis, a serious form of gum disease.

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 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 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

water, sorbitol, calcium carbonate, silica, PEG-32, sodium lauryl sulphate, flavor, cellulose gum, sodium bicarbonate, flavor, titanium dioxide, sodium saccharin, sodium benzoate, benzoic acid, zinc citrate

QUESTIONS

Questions or comments? www.sleeksensation.com

PRINCIPAL DISPLAY PANEL

Dental Plus Whitening

Anticavity Fluoride Toothpaste

Net Wt 5.1 oz (145 g)

INGREDIENTS AND APPEARANCE

DENTAL PLUS WHITENING 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62685-216
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62685-216-03	1 in 1 BOX	02/01/2021
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	02/01/2021

Labeler - tropical degil cosmetics industries ltd (600437230)

Establishment
Name	Address	ID/FEI	Business Operations
tropical degil cosmetics industries ltd		600437230	manufacture(62685-216)