TOMS CHILDRENS ANTICAVITY MOUTHWASH SILLY STRAWBERRY- sodium fluoride rinse

Toms Childrens Anticavity Mouthwash Silly Strawberry by

Drug Labeling and Warnings

Toms Childrens Anticavity Mouthwash Silly Strawberry 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 (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:

• use twice 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

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)

SPL UNCLASSIFIED SECTION

Dist. by Tom's of Maine, Inc., Kennebunk, ME 04043 U.S.A.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

New!

SINCE 1970
Tom's
OF MAINE®

alcohol-free | natural

children's anticavity

fluoride rinse

cavity protection for
a healthy smile

tastes great

dye free

silly
strawberry™

16 FL OZ (473 mL)

P9929760

IMPORTANT: Read
directions for proper use

INGREDIENTS AND APPEARANCE

TOMS CHILDRENS ANTICAVITY MOUTHWASH SILLY STRAWBERRY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-840
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
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
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-840-52	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/18/2018

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