ORTHOWASH- sodium fluoride rinse 
3M ESPE Dental Products

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 ingredient (in each 10ml)

0.044% Sodium fluoride in an acidulated phosphate solution

Purpose

Anticavity

Use

aids in the prevention of dental decay

Warnings

Keep out of reach of children. If pregnant or breast-feeding, ask a health professional

before use. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

children under 6 years of age:

  • consult a dentist or doctor

Other information

do not freeze or expose to extreme heat

Inactive ingredients

water, glycerin, flavoring, sodium benzoate, sodium phosphate, phosphoric acid, FD&C Red #40, FD&C Blue #1

Questions or comments?

call toll free at 1-800-634-2249

Principal Display Panel – Box Label

Grape

NDC 48878-3215-5

3M ESPE

OrthoWash™

Sodium Fluoride in an Acidulated Phosphate Solution

Daily Fluoride Treatment Rinse

Helps prevent tooth decay

Helps prevent white spots

And decay around braces

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

16 fl oz (480ml)

Principal Display Panel – Box Label

Principal Display Panel – Box Label

Strawberry

NDC 48878-3214-5

3M ESPE

OrthoWash™

Sodium Fluoride

in an Acidulated

Phosphate Solution

Daily Fluoride

Treatment Rinse

Helps prevent tooth decay

Helps prevent white spots

And decay around braces

IMPORTANT: Read

directions thoroughly.

OMNI

Contents:

16 fl oz

(480ml)

Principal Display Panel – Box Label
ORTHOWASH 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-3215
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion0.199 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
glycerin (UNII: PDC6A3C0OX)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium phosphate (UNII: SE337SVY37)  
phosphoric acid (UNII: E4GA8884NN)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (GRAPE) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48878-3215-51 in 1 BOX04/01/200204/01/2016
1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/200204/01/2016
ORTHOWASH 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48878-3214
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
glycerin (UNII: PDC6A3C0OX)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium phosphate (UNII: SE337SVY37)  
phosphoric acid (UNII: E4GA8884NN)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (STRAWBERRY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48878-3214-51 in 1 BOX04/01/200204/01/2016
1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/200204/01/2016
Labeler - 3M ESPE Dental Products (801390852)

Revised: 8/2016
Document Id: b8456ce6-2874-4dd5-8eb0-f4a394320c53
Set id: 37d407ae-d5b1-4c67-8894-1d419ae36c69
Version: 2
Effective Time: 20160823
 
3M ESPE Dental Products