ANTICAVITY- sodium fluoride rinse 
TOPCO Associates LLC

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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Top Care 971.001 971AB

Active Ingredients

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warning

for this product

Keep out of Reach of Children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately

Directions

Adults and children 6 years of age and older:

Other information

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Zero Anticavity Mouthwash.

This TOPCARE product is laboratory tested to guarantee its highest quality.  Your total satisfaction is guaranteed.

Adverse reactions section

DISTRIBUTED BY TOPCO ASOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139 TOPCO

topcare@topco.com  www.topcarebrand.com

principal display panel

COMPARE TO LISTERINE TOTAL CARE ZERO ANTICAVITY MOUTHWASH

Top Care

everyday

ALCOHOL FREE - FLUORIDE

Anticavity

Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

FRESH MINT

6 Benefits

*This product is not intended to replace brushing or flossing

IMPORTANT:

Read direction for proper use.

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-971
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
EUCALYPTOL (UNII: RV6J6604TK)  
THYMOL (UNII: 3J50XA376E)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SPEARMINT OIL (UNII: C3M81465G5)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-971-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/19/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/19/2013
Labeler - TOPCO Associates LLC (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-971)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(36800-971)

Revised: 5/2022
Document Id: a563905c-9caa-45f2-97dd-eb4f22c6ac82
Set id: a9b8b2fe-0a60-4f65-b6f6-aae8509c919f
Version: 11
Effective Time: 20220524
 
TOPCO Associates LLC