family wellness 163.005/163ag

family wellness 163.005/163ag
SPL v15
SPL
SPL Set ID 32ebc633-5338-4d5a-b075-f10b24761248
Route
oral
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.1 mg)
Inactive Ingredients
water alcohol sorbitol poloxamer 407 eucalyptol methyl salicylate menthol phosphoric acid saccharin sodium thymol sodium phosphate, dibasic, anhydrous sucralose fd&c red no. 40 fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2011-12-14

Purpose

Anticavity

Description

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


Medication Information

Purpose

Anticavity

Directions

Adults and children 12 years of age and older:

  • use twice daily after brushing your teeth with toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute 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 12 years of age: consult a dentist or doctor
Other Information
  • store at controlled room temperature 20⁰-25⁰ C (68⁰ - 77⁰F)
  • cold weather may temporarily cloud this product
Inactive Ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Description

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

Principal Display Panel

Sealed with printed neckband for your protection.

Do not use if band around cap is broken or missing.

FAMILY WELLNESS ™

COMPARE TO LISTERINE ® TOTAL CARE FRESH MINT ANTICAVITY MOUTHWASH*

MINT

ANTICAVITY FLUORIDE RINSE

Sodium Fluoride and Acidulated Phosphate Topical Solution

MINT FLAVOR ANTICAVITY FLUORIDE MOUTHWASH

  • Multiple benefits in one
  • Helps prevent cavities and restore enamel
  • Helps strengthen teeth

1 L (1.05 QT) 33.8 FL OZ

Use

aids in the prevention of dental cavities

Warning

for this product

Disclaimer

*This product is not manufacturd or distributed by Johnson & Johnson Corporation, distributerof Listerine ® Total Care Fresh Mint Anticavity Mouthwash.

Adverse Reaction

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

MADE IN THE US WITH US AND FOREIGN COMPONENTS.

NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or Exchange.

DSP-TN-21091

DSP-MO-20087

Active Ingredient

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

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.


Structured Label Content

Purpose

Anticavity

Directions

Adults and children 12 years of age and older:

  • use twice daily after brushing your teeth with toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute 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 12 years of age: consult a dentist or doctor
Other Information (Other information)
  • store at controlled room temperature 20⁰-25⁰ C (68⁰ - 77⁰F)
  • cold weather may temporarily cloud this product
Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Principal Display Panel (principal display panel)

Sealed with printed neckband for your protection.

Do not use if band around cap is broken or missing.

FAMILY WELLNESS ™

COMPARE TO LISTERINE ® TOTAL CARE FRESH MINT ANTICAVITY MOUTHWASH*

MINT

ANTICAVITY FLUORIDE RINSE

Sodium Fluoride and Acidulated Phosphate Topical Solution

MINT FLAVOR ANTICAVITY FLUORIDE MOUTHWASH

  • Multiple benefits in one
  • Helps prevent cavities and restore enamel
  • Helps strengthen teeth

1 L (1.05 QT) 33.8 FL OZ

Use

aids in the prevention of dental cavities

Warning

for this product

Disclaimer

*This product is not manufacturd or distributed by Johnson & Johnson Corporation, distributerof Listerine ® Total Care Fresh Mint Anticavity Mouthwash.

Adverse Reaction

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

MADE IN THE US WITH US AND FOREIGN COMPONENTS.

NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or Exchange.

DSP-TN-21091

DSP-MO-20087

Active Ingredient (Active ingredient)

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

Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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