ANTICAVITY - sodium fluoride mouthwash
American Sales Company

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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Drug Facts

Active Ingredient
Sodium Fluoride 0.0221% (0.01% Fluoride ion)

Purpose
Anticavity

Use •aids in the prevention of dental cavities

Warning

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 12 years of age and older
• use twice daily after brushing your teeth with a toothpaste
• vigorously swish 10 ml (2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
• do not swallow the rinse
• do not eat or drink for 30 minutes after rinsing
• supervise children as necessary until capable of using without supervision
• children under 12 years of age: consult a dentist or doctor

Inactive ingredients water, sorbitol solution, alcohol (21.6%), flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, sucralose and/or sodium saccharin, dibasic sodium phosphate, D+C red no. 33, FD+C blue no. 1, FD+C yellow no. 6

Other information
• store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
• cold weather may temporarily cloud this product

DISTRIBUTED BY
AMERICAN SALES COMPANY
4201 WALDEN AVENUE, LANCASTER NY 14086
www.care1.info
Quality Guaranteed Or Your Money Back
DSP-TN-15000
DSP-MO-34
SDS-TN-15012

CARE ONE
ANTI-CAVITY
MOUTHWASH
Sodium fluoride Acidulated Phosphate Topical Solution
•Restores Enamel
•Freshens Breath
•Helps prevent cavities
•Helps strengthen teeth
Helps Kill germs that cause Bad Breath
EUCALYPTUS MINT
IMPORTANT: read directions for proper use.
33.8 FL OZ (1 LITER)

ANTICAVITY
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:41520-163
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (FLUORIDE ION)	SODIUM FLUORIDE	999.5 mL in 100 L

Ingredient Name	Strength
Inactive Ingredients
WATER
SORBITOL
ALCOHOL
POLOXAMER 407
SODIUM LAURYL SULFATE
PHOSPHORIC ACID
SODIUM PHOSPHATE, DIBASIC
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C YELLOW NO. 6

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-163-86	1 L in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/12/2005

Labeler - American Sales Company (809183973)

Registrant - Vi Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon		790752542	manufacture

Revised: 2/2012

Document Id: e5721c1c-1d93-401b-af4a-1e24a220658b

Set id: 548a5496-b640-4647-9ae1-ae01cb1d8aaa

Version: 1

Effective Time: 20120215

American Sales Company