Top Care 213.002/213ae Rev 2

Top Care 213.002/213ae Rev 2
SPL v16
SPL
SPL Set ID f760f8f8-0c74-4a6e-b5c9-cc82b8758a45
Route
ORAL
Published
Effective Date 2025-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Water Sorbitol Menthol Methyl Salicylate Cetylpyridinium Chloride Saccharin Sodium Poloxamer 407 Polysorbate 20 Propylene Glycol Sodium Phosphate Sodium Phosphate, Dibasic, Monohydrate Edetate Calcium Disodium Edetate Disodium Anhydrous Sodium Benzoate Potassium Sorbate Benzyl Alcohol Fd&c Green No. 3 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2003-10-20

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Anticavity rinse

Adverse Reactions

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ® Anticavity Fluoride Mouthwash. DISTRIBUTED BY: TOCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 (C) TOPCO VIJ717  QUESTIONS? 1-888-423-0139 [email protected]  www.topcarebrand.com QUALITY GUARANTEED This Top Care product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.


Medication Information

Purpose

Anticavity rinse

Adverse Reactions

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ®Anticavity Fluoride Mouthwash.

DISTRIBUTED BY: TOCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

(C) TOPCO VIJ717  QUESTIONS? 1-888-423-0139

[email protected]  www.topcarebrand.com

QUALITY GUARANTEED

This Top Care product is laboratory tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Use

aids in the prevention of dental cavities

Warning

for this product

Directions
  • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do now 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
Questions?

Call 1-888-423-0139

Active Ingredient

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

Other Information
  • store at room temperature
Inactive Ingredients

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Principal Display Panel

COMPARE TO ACT ®*

TopCare ®

everyday™

ALCOHOL FREE

Anticavity

Fluoride Mouth Rinse

MINT

  • Helps prevent cavities
  • Helps strengthen teeth
  • Freshens breath

IMPORTANT: Read direction for proper use.

ADA Accepted 

American Dental Association

  • Helps prevent cavities

18 FL OZ (1 PT 2 FL OZ) 532 mL

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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.


Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity rinse

Warning

for this product

Directions
  • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do now 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
Questions?

Call 1-888-423-0139

Active Ingredient (Active ingredient)

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

Adverse Reactions (Adverse reactions)

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ®Anticavity Fluoride Mouthwash.

DISTRIBUTED BY: TOCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

(C) TOPCO VIJ717  QUESTIONS? 1-888-423-0139

[email protected]  www.topcarebrand.com

QUALITY GUARANTEED

This Top Care product is laboratory tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Principal Display Panel (Principal display panel)

COMPARE TO ACT ®*

TopCare ®

everyday™

ALCOHOL FREE

Anticavity

Fluoride Mouth Rinse

MINT

  • Helps prevent cavities
  • Helps strengthen teeth
  • Freshens breath

IMPORTANT: Read direction for proper use.

ADA Accepted 

American Dental Association

  • Helps prevent cavities

18 FL OZ (1 PT 2 FL OZ) 532 mL

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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