REMBRANDT- sodium monofluorophosphate paste, dentifrice

Rembrandt by

Drug Labeling and Warnings

Rembrandt by is a Otc medication manufactured, distributed, or labeled by Ashtel Studios, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredient: Sodium Monofluorophosphate 0.76%

PURPOSE

Purpose: Anticavity

INDICATIONS & USAGE

Use: Aids in the prevention of dental cavities.

WARNINGS

Warnings: Keep out of reach of children under 6 years of age. If more than amount used for brushing is accidentally swallowed,
seek medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions: Adults and children 2 years of age & older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. Children under 6 years of age: Use a pea-sized amount and instruct 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. Do not swallow.

INACTIVE INGREDIENT

Inactive ingredients: CALCIUM CARBONATE, SORBITOL, TREATED WATER, SILICA, SODIUM LAURYL SULPHATE, FLAVOR, SODIUM CARBOXY METHYL CELLULOSE, SODIUM SILICATE, TETRA SODIUM PYROPHOSPHATE, BENZYL ALCOHOL, SODIUM SACCHARIN, PROPYLPARABEN.

SPL UNCLASSIFIED SECTION

LICENSED BY RANIR, LLC. ALL RIGHTS RESERVED.      MADE IN INDIA
DIST. BY: ASHTEL STUDIOS, INC., ONTARIO, CA 91761  COMMENTS OR QUESTIONS?
1-877-274-8358 TOLL FREE IN U.S.A. 1-909-434-0911 INTERNATIONAL

Q

QUICK CLEAN®

TOOTHPASTE WITH FLUORIDE

Packaging

INGREDIENTS AND APPEARANCE

REMBRANDT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-031
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-031-01	10 g in 1 TUBE; Type 0: Not a Combination Product	12/15/2019
2	NDC: 70108-031-02	20 g in 1 TUBE; Type 0: Not a Combination Product	12/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/15/2019

Labeler - Ashtel Studios, Inc (148689180)