OUTRAGEOUS ORANGE ANTICAVITY - OFT51 MRT- sodium monofluorophosphate paste, dentifrice

Outrageous Orange Anticavity - OFT51 MRT by

Drug Labeling and Warnings

Outrageous Orange Anticavity - OFT51 MRT by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
• children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• children under 2 years: ask 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)

INGREDIENTS AND APPEARANCE

OUTRAGEOUS ORANGE ANTICAVITY - OFT51 MRT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-911
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.0014 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	ORANGE (Orange Mango)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-911-51	144 g in 1 TUBE; Type 0: Not a Combination Product	11/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	11/15/2019

Labeler - Tom's of Maine, Inc. (052764354)

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-911)