Family Wellness 318.003/318ah-ai

Family Wellness 318.003/318ah-ai
SPL v17
SPL
SPL Set ID 7a581e30-b062-498c-aefa-8fad58517afc
Route
ORAL
Published
Effective Date 2025-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.6 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Benzoic Acid Poloxamer 407 Sodium Benzoate Caramel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1991-01-22 Until 2015-03-28

Description

Eucalyptol 0.092% Menthol 0.042% Methyl Salicylate 0.060% Tymol 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% Tymol 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 under 12 years of age - consult a dentist or doctor

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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributer of Original Listerine 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°-77°F).

Active Ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Tymol 0.064%

Inactive Ingredients

water, alcohol 26.9% benzoic acid, poloxamer 407, sodium benzoate, caramel

Principal Display Panel

Sealed with printed neckband for you protection.

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

FAMILY Wellness™

COMPARE TO LISTERINE ® ANTISEPTIC MOUTHWASH*

ORIGINAL  

ANTISEPTIC 

MOUTHRINSE

Antigingivitis/Antiplaque

Mouthrinse

  • Kills germs that cause bad breath, plaque and gingivitis gum disease

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 under 12 years of age - consult a dentist or doctor

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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributer of Original Listerine 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 (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°-77°F).

Active Ingredients (Active ingredients)

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Tymol 0.064%

Inactive Ingredients (Inactive ingredients)

water, alcohol 26.9% benzoic acid, poloxamer 407, sodium benzoate, caramel

Principal Display Panel (Principal display panel)

Sealed with printed neckband for you protection.

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

FAMILY Wellness™

COMPARE TO LISTERINE ® ANTISEPTIC MOUTHWASH*

ORIGINAL  

ANTISEPTIC 

MOUTHRINSE

Antigingivitis/Antiplaque

Mouthrinse

  • Kills germs that cause bad breath, plaque and gingivitis gum disease

1 L (1.05 QT) 33.8 FL OZ

Stop Use and Ask A Dentist (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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