REMBRANDT- sodium monofluorophosphate paste, dentifrice 
Ashtel Studios, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

REMBRANDT® TOOTHPASTE WITH FLUORIDE

Drug Facts

Active Ingredient: Sodium Monofluorophosphate 0.76%

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 amount used for brushing is accidentally swallowed,
seek medical help or contact a Poison Control Center right away.

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 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.

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

image description

REMBRANDT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-031
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70108-031-0110 g in 1 TUBE; Type 0: Not a Combination Product12/15/2019
2NDC:70108-031-0220 g in 1 TUBE; Type 0: Not a Combination Product12/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/15/2019
Labeler - Ashtel Studios, Inc (148689180)

Revised: 12/2019
Document Id: 599120b2-01f4-49cf-9b4f-fd74e0a13224
Set id: cd780a97-ef82-4b15-9b96-f78e808501e4
Version: 1
Effective Time: 20191209
 
Ashtel Studios, Inc