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Name:Advancew White Sensitivemaximum Strength Sensitivity Relief With Whitening
Manufacturer:Church & Dwight Co., Inc.
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

ADVANCEW WHITE SENSITIVE MAXIMUM STRENGTH SENSITIVITY RELIEF WITH WHITENING - sodium fluoride and potassium nitrate paste, 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        

Potassium nitrate (5.0%)
Sodium fluoride (0.24%)

Purpose
Antihypersensitivity
Anticavity toothpaste

Use    aids in the prevention of dental decay
          builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact   

Warnings
When using this product
do not use longer than 4 weeks unless recommended by a dentist or physician.

Stop use and ask a dentist if the problem persist or worsens.  Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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

adults and children 12 years and older             apply at least 1-inch strip of the product onto a soft bristle toothbrush.  Brush teeth for at least one minute, preferably after each meal or at                                                                               least twice a day (morning and evening) or as recommended bya dentist or physician .  Make sure to brush all sensitive areas of the teeth.
children under 12 years                                       consult a dentist or physician

Inactive ingredients   sodium bicarbonate (baking soda), water, sorbitol, glycerin, sodium saccharin, cellulose gum, flavor, sodium lauryl sulfate, sodium lauroyl sarcosinate, titanium dioxide

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

Fresh Mint

ADVANCE WHITE
SENSITIVE with Whitening

MAXIMUM STRENGTH SENSITIVITY RELIEF

NET WT. 4.5 OZ. (127g)

FRESH FROM THE DENTIST FEELING OF CLEAN

Carton imageCarton image


ADVANCEW WHITE SENSITIVE  MAXIMUM STRENGTH SENSITIVITY RELIEF WITH WHITENING
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-602
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
POTASSIUM NITRATE (POTASSIUM CATION) POTASSIUM NITRATE 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE  
WATER  
SORBITOL  
GLYCERIN  
SACCHARIN SODIUM  
CARBOXYMETHYLCELLULOSE SODIUM  
SODIUM LAURYL SULFATE  
SODIUM LAUROYL SARCOSINATE  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score     
Shape Size
Flavor MINT (Fresh Mint) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10237-602-45 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 127 g in 1 TUBE This package is contained within the CARTON (10237-602-45)
2 NDC:10237-602-63 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
2 178 g in 1 TUBE This package is contained within the CARTON (10237-602-63)
3 NDC:10237-602-75 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
3 212 g in 1 TUBE This package is contained within the CARTON (10237-602-75)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 03/01/2001

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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