OUTRAGEOUS ORANGE ANTICAVITY - OFT51 MRT- sodium monofluorophosphate paste, dentifrice 
Tom's of Maine, 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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Outrageous Orange Anticavity - OFT51 MRT

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).

Directions

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

glycerin, water, calcium carbonate, hydrated silica, benzyl alcohol, sodium lauryl sulfate, carrageenan, natural flavor, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Citrus aurantium dulcis (Orange) juice, Ananas sativus (Pineapple) fruit juice, Fragaria ananassa (Strawberry) fruit juice.

Questions?

1-800-FOR-TOMS (1-800-367-8667)

PRINCIPAL DISPLAY PANEL - 144 g Tube Label

20% more!
vs. 4.2oz size

SINCE 1970
Tom's
OF MAINE®

ADA
Accepted
American
Dental
Association ®

natural
children's

fluoride toothpaste

fights cavities
tastes great
dye free

with real
fruit juice!

outrageous
orange mango

NET WT 5.1 OZ (144 g)

PRINCIPAL DISPLAY PANEL - 144 g Tube Label
OUTRAGEOUS ORANGE ANTICAVITY - OFT51 MRT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-911
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0014 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
ORANGE (UNII: 5EVU04N5QU)  
LEMON JUICE (UNII: AGN709ANTJ)  
MANGO JUICE (UNII: IU6I1JNV24)  
ORANGE JUICE (UNII: 5A9KE2L9L3)  
PINEAPPLE JUICE (UNII: O4KOG0B1KC)  
STRAWBERRY JUICE (UNII: U8NS58UGW0)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorORANGE (Orange Mango) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-911-51144 g in 1 TUBE; Type 0: Not a Combination Product11/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/15/2019
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 11/2019
Document Id: 54413508-1e8b-4d1c-89f3-89d7d42e418a
Set id: 19de1e71-ab94-415f-b66d-e5748dea8317
Version: 2
Effective Time: 20191108
 
Tom's of Maine, Inc.