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Name:Advance Whitebrilliant Sparkle Tartar Control
Manufacturer:Church & Dwight Co., Inc.
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

ADVANCE WHITE BRILLIANT SPARKLE TARTAR CONTROL - sodium fluoride gel, dentifrice 
Church & Dwight Co., 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.

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DRUG FACTS

Active ingredients        
Sodium fluoride (0.24%)

Purpose
Anticavity toothpaste

Use    aids in the prevention of dental decay   

Warning

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           do not swallow    supervise children as necessary until capable of using without supervision

adults and children 2 years and older           brush teeth throughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years                                    instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years                                    consult a dentist or physician

Inactive ingredients   Sorbitol, Sodium Bicarbonate (baking soda), Water, Hydrated Silica, Glycerin, Tetrasodium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Sodium Saccharin, Sodium Lauroyl Sarcosinate, Cellulose Gum, Blue 1, Yellow 5.

Questions or comments?  Call 1-800-786-5135 Monday-Friday 9am-5pm ET or visit www.myoralcare.com

Principal Display Panel

ARM AND HAMMER The Standard of Purity
Fluoride Anti-Cavity Toothpaste     

ADVANCE WHITE      Brilliant Sparkle Gel
Tartar Control

NET WT. 4.3 OZ. (121g)

FRESH FROM THE DENTIST FEELING OF CLEAN

Carton imageCarton image


ADVANCE WHITE  BRILLIANT SPARKLE TARTAR CONTROL
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-606
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.4 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL  
SODIUM BICARBONATE  
WATER  
HYDRATED SILICA  
GLYCERIN  
SODIUM PYROPHOSPHATE  
SODIUM LAURYL SULFATE  
SACCHARIN SODIUM  
SODIUM LAUROYL SARCOSINATE  
CARBOXYMETHYLCELLULOSE SODIUM  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
Product Characteristics
Color green Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-606-43 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 121 g in 1 TUBE This package is contained within the CARTON (10237-606-43)
2 NDC:10237-606-60 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
2 170 g in 1 TUBE This package is contained within the CARTON (10237-606-60)
3 NDC:10237-606-72 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
3 204 g in 1 TUBE This package is contained within the CARTON (10237-606-72)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 02/23/2004

Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
Name Address ID/FEI Operations
Church & Dwight Co., Inc. 043690812 manufacture

Revised: 11/2010 Church & Dwight Co., Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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