Family Wellness Green Mint Mouthwash

Family Wellness Green Mint Mouthwash
SPL v4
SPL
SPL Set ID 8bc689f1-6623-a054-e053-2995a90a9072
Route
ORAL
Published
Effective Date 2019-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.092 g) Menthol (0.042 g) Salicylic Acid (0.06 g) Thymol (0.064 g)
Inactive Ingredients
D&c Yellow No. 10 Sodium Citrate Poloxamer 407 Water Alcohol Sorbitol Benzoic Acid Saccharin Sodium Fd&c Green No. 3

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-06-20

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use helps control plaque that leads to gingivitis

Dosage and Administration

Directions

– adults and children 12 years of age and older: vigorously swish 20 mL (2/3 FL OS or 4 teaspoonfuls) between teeth 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 brushing or flossing

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information cold weather may cloud this product. Its antiseptic properties are not affected . Store at room temperature (59° - 77°F)

Section 50565-1

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.

Section 50566-9

Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks

Section 50570-1

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.

Section 51727-6

Inactive ingredients water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3

Section 51945-4

COMPARE TO LISTERINE® FRESH BURST*

FAMILY wellness™

GREEN MINT

MOUTHWASH

DEEP CLEAN FOR FRESHER BREATH

Helps Kill Germs that Cause Bad Breath, Plaque and Gingivitis Gum Disease

33.8 FL OZ (1000 mL)

Section 55105-1

Purpose

Antigingivitis, Antiplaque

Antigingivitis, Antiplaque

Section 55106-9

Active ingredients

Eucalyptol 0.092%, Menthol 0.042%

Methyl Salicylate 0.060%, Thymol 0.064%


Structured Label Content

Indications and Usage (34067-9)

Use helps control plaque that leads to gingivitis

Dosage and Administration (34068-7)

Directions

– adults and children 12 years of age and older: vigorously swish 20 mL (2/3 FL OS or 4 teaspoonfuls) between teeth 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 brushing or flossing

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information cold weather may cloud this product. Its antiseptic properties are not affected . Store at room temperature (59° - 77°F)

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3

Section 51945-4 (51945-4)

COMPARE TO LISTERINE® FRESH BURST*

FAMILY wellness™

GREEN MINT

MOUTHWASH

DEEP CLEAN FOR FRESHER BREATH

Helps Kill Germs that Cause Bad Breath, Plaque and Gingivitis Gum Disease

33.8 FL OZ (1000 mL)

Section 55105-1 (55105-1)

Purpose

Antigingivitis, Antiplaque

Antigingivitis, Antiplaque

Section 55106-9 (55106-9)

Active ingredients

Eucalyptol 0.092%, Menthol 0.042%

Methyl Salicylate 0.060%, Thymol 0.064%


Advanced Ingredient Data


Raw Label Data

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