CHILDRENS OUTRAGEOUS ORANGE MANGO- sodium monofluorophosphate paste, dentifrice

Childrens by

Drug Labeling and Warnings

Childrens 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% (0.13% 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, natural flavors, Chondrus crispus (carrageenan), sodium lauryl sulfate.

Questions?

1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET

PRINCIPAL DISPLAY PANEL - 119 g Tube

SINCE 1970
Tom's™
OF MAINE

ADA
Accepted
American
Dental
Association ®

natural
children's

prevents
cavities

tastes great

fluoride toothpaste

outrageous
orange mango™

NET WT 4.2 OZ (119 g)

INGREDIENTS AND APPEARANCE

CHILDRENS  OUTRAGEOUS ORANGE MANGO
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-127
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O)	Sodium Monofluorophosphate	0.0076 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Calcium carbonate (UNII: H0G9379FGK)
Hydrated silica (UNII: Y6O7T4G8P9)
Orange (UNII: 5EVU04N5QU)
Carrageenan (UNII: 5C69YCD2YJ)
sodium lauryl sulfate (UNII: 368GB5141J)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	ORANGE (Orange-mango with other natural fruit flavors)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-127-04	1 in 1 CARTON
1		113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/30/2010

CHILDRENS  OUTRAGEOUS ORANGE MANGO
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-830
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O)	Sodium Monofluorophosphate	0.0076 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Calcium carbonate (UNII: H0G9379FGK)
Hydrated silica (UNII: Y6O7T4G8P9)
Orange (UNII: 5EVU04N5QU)
Carrageenan (UNII: 5C69YCD2YJ)
sodium lauryl sulfate (UNII: 368GB5141J)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	ORANGE (Orange-mango with other natural fruit flavors)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-830-94	119 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/30/2010

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		052764354	MANUFACTURE