Family Wellness 855.000/855aa-ac

Family Wellness 855.000/855aa-ac
SPL v4
SPL
SPL Set ID c74250c1-785e-49da-9e53-88007bdfdaf5
Route
ORAL
Published
Effective Date 2025-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Thymol (0.64 mg) Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.6 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Benzoic Acid Zinc Chloride Sodium Benzoate Sucralose Saccharin Sodium Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-07

Description

Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

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


Medication Information

Purpose

Antigingivitis, Antiplaque

Adverse Reactions

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

Description

Eucalyptol 0.092% Menthol 0.042% Methyl salicylate 0.060% Thymol 0.064%

Use

helps control plaque that leads to gingivitis

Warnings

for this product

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow

children 6 years to under 12 years of age - supervise use

children under 6 yeard of age - do not use

  • this rinse is not intended to replace brushing or flossing
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of Listerine ®Ultraclean ®Cool Mint Antiseptic Mouthwash*

Do Not Use

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Other Information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-86°F)

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients

 water, alcohol (21.6%), sorbitol, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green 3

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 ® ULTRACLEAN ® COOL MINT ® ANTISEPTIC MOUTHWASH*

BLUE MINT

TARTAR CONTROL

PLUS ANTISEPTIC

MOUTHRINSE

ANTIGINGIVITIS/ANTIPLAQUE

Kills germs that cause bad breath, plaque & the gum disease gingivitis

  • Long lasting clean feel
  • Fresh breath with mouth-cooling sensation
  • Helps control tartar that can discolor teeth

FIGHTS PLAQUE & GINGIVITIS

1 L (1.05 QT) 33.8 FL OZ

Stop Use and Ask A Dentist If

gingivitis, bleeding, or redness persists for more than 2 weeks.

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

helps control plaque that leads to gingivitis

Purpose

Antigingivitis, Antiplaque

Warnings

for this product

Directions

adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow

children 6 years to under 12 years of age - supervise use

children under 6 yeard of age - do not use

  • this rinse is not intended to replace brushing or flossing
Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of Listerine ®Ultraclean ®Cool Mint Antiseptic Mouthwash*

Do Not Use (Do not use)

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serious form of gum disease.

Adverse Reactions

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

Other Information (Other information)

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-86°F)

Active Ingredients (Active ingredients)

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Inactive Ingredients (Inactive ingredients)

 water, alcohol (21.6%), sorbitol, flavor, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, sodium saccharin, green 3

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 ® ULTRACLEAN ® COOL MINT ® ANTISEPTIC MOUTHWASH*

BLUE MINT

TARTAR CONTROL

PLUS ANTISEPTIC

MOUTHRINSE

ANTIGINGIVITIS/ANTIPLAQUE

Kills germs that cause bad breath, plaque & the gum disease gingivitis

  • Long lasting clean feel
  • Fresh breath with mouth-cooling sensation
  • Helps control tartar that can discolor teeth

FIGHTS PLAQUE & GINGIVITIS

1 L (1.05 QT) 33.8 FL OZ

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)

gingivitis, bleeding, or redness persists for more than 2 weeks.

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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