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

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

Use

aids in the prevention of dental cavities

Warning

for this product

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
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)

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

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

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

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Warning

for this product

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
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)

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

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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