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NDC 36800-0971-86 Anticavity 0.02 mg/mL Details

Anticavity 0.02 mg/mL

Anticavity is a ORAL RINSE in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO Associates LLC. The primary component is SODIUM FLUORIDE.

Product Information

NDC	36800-0971
Product ID	36800-971_a563905c-9caa-45f2-97dd-eb4f22c6ac82
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Anticavity
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Fluoride
Product Type	HUMAN OTC DRUG
Dosage Form	RINSE
Route	ORAL
Active Ingredient Strength	0.02
Active Ingredient Units	mg/mL
Substance Name	SODIUM FLUORIDE
Labeler Name	TOPCO Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0971-86 (36800097186)

Pricing Information	N/A
NDC Package Code	36800-971-86
Billing NDC	36800097186
Package	1000 mL in 1 BOTTLE, PLASTIC (36800-971-86)
Marketing Start Date	2013-09-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a9b8b2fe-0a60-4f65-b6f6-aae8509c919f Details

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:

use twice daily after brushing your teeth with a toothpaste
vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 miute 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

Other information

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

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

[email protected] 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

Alcohol free
Helps prevent cavities
Strengthens teeth
Restores enamel
Kills bad breath germs
Cleans entire mouth*

*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

INGREDIENTS AND APPEARANCE

ANTICAVITY

sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-971
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-971-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/19/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	09/19/2013

Labeler - TOPCO Associates LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-971)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-971)

Revised: 5/2022

Document Id: a563905c-9caa-45f2-97dd-eb4f22c6ac82

Set id: a9b8b2fe-0a60-4f65-b6f6-aae8509c919f

Version: 11

Effective Time: 20220524