ANTICAVITY FLUORIDE RINSE- anticavity fluoride mouthwash
Rite Aid

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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Anticavity Fluoride Rinse

Active ingredient

Sodium ion 0.05% (0.02% w/v fluoride ion)

Purpose

anticavity rinse

Use

aids in the prevention of dental cavities

warnings

for this product

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

DIRECTIONS

adults and children 6 yeard of age and older: use once a day after brushing your teeth with a toothpaste
remove cap
pour 10 millilters (10 mL mark on inside of cap); do not fill above the 10 mL mark
vigorously swish 10 millilters of rinse between your teeth for 1 minute and them 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 age: consult a dentist or doctor

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Other information

• store at room temperature

adverse reaction

DISTRIBUTE BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

SATISFACTION GUARANTEE

iF YOU ARE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY

principal display panel

compare to the ative ingredient in Act Anticavity Kids Fluoride Rinse

RITE

AID

PHARAMACY

kids

oral care

anticavity

fluoride

rinse

bubble gum flavor

alcohol free

strong cavity

protection

ADA

Accepted

American

Dental

Association

IMPORTANT: READ INSTRUCTIONS FOR PROPER USE

18 FL OZ (532 mL)

ANTICAVITY FLUORIDE RINSE
anticavity fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0004
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-0004-1	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/08/2004	04/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	04/08/2004	04/08/2020

Labeler - Rite Aid (014578892)

Registrant - Vi Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon		790752542	manufacture(11822-0004)

Revised: 4/2020

Document Id: 2c6ff4e0-8e29-4f41-944c-f8a31f049eed

Set id: 68da2779-f5d5-47d8-88f1-118647193ef1

Version: 9

Effective Time: 20200408

Rite Aid