TOMS CHILDRENS ANTICAVITY MOUTHWASH SILLY STRAWBERRY- sodium fluoride rinse 
Tom's of Maine, Inc.

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Tom's Children's Anticavity Mouthwash Silly Strawberry

Drug Facts

Active ingredient (in each 10mL)

Sodium fluoride 0.04% (0.02% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

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:

Children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, glycerin, Aloe barbadensis leaf juice1, xylitol, sodium phosphate, propanediol, benzoic acid, natural flavor, phosphoric acid, menthol, Fragaria ananassa (Strawberry) fruit juice, Ananas sativus (Pineapple) fruit juice, Citrus aurantium dulcis (Orange) juice, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Rebaudioside A


1
organic

Questions?

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

Dist. by TOM'S OF MAINE, INC., KENNEBUNK, ME 04043 U.S.A.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

SINCE 1970
Tom's
OF MAINE®

alcohol-free | natural

children's anticavity

fluoride rinse

cavity protection for
a healthy smile

tastes great

dye free

ADA
Accepted
American
Dental
Association®

silly
strawberry

16 FL OZ (473 mL)

with real
fruit juice!

P9937074

IMPORTANT: Read
directions for proper use

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
TOMS CHILDRENS ANTICAVITY MOUTHWASH SILLY STRAWBERRY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-840
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
STRAWBERRY JUICE (UNII: U8NS58UGW0)  
PINEAPPLE JUICE (UNII: O4KOG0B1KC)  
ORANGE JUICE (UNII: 5A9KE2L9L3)  
LEMON JUICE (UNII: AGN709ANTJ)  
MANGO JUICE (UNII: IU6I1JNV24)  
REBAUDIOSIDE A (UNII: B3FUD0528F)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-840-52473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02112/18/2018
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 1/2024
Document Id: 15d5c2e4-8e09-49cf-911c-4894faea2995
Set id: 998c6f35-20f4-4cb8-bc48-6aa39e61481a
Version: 10
Effective Time: 20240118
 
Tom's of Maine, Inc.