Family Wellness Ultra Mouthrinse, Arctic Mint

Family Wellness Ultra Mouthrinse, Arctic Mint
SPL v2
SPL
SPL Set ID a93ca8e8-9b82-44a6-e053-2a95a90aa9e7
Route
ORAL
Published
Effective Date 2020-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (0.42 mg) Thymol (0.64 mg) Eucalyptol (0.92 mg) Salicylic Acid (0.6 mg)
Inactive Ingredients
Benzoic Acid Sorbitol Sucralose Poloxamer 407 Water Alcohol Sodium Benzoate Saccharin Fd&c Blue No. 1 Zinc Chloride

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-29

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 OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow
children 6 years to under 12 years of age supervise use
children under 6 years do not use
  • 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° - 86°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 periodonititis, a serious form of gum disease.

Section 51727-6

Inactive ingredients water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, flavor, sodium saccharin, blue 1.

Section 51945-4

COMPARE TO LISTERINE® ULTRACLEAN*

FAMILY wellness™

ULTRA

MOUTHWASH

ANTISEPTIC MOUTHRINSE

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

3.8 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 OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow
children 6 years to under 12 years of age supervise use
children under 6 years do not use
  • 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° - 86°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 periodonititis, a serious form of gum disease.

Section 51727-6 (51727-6)

Inactive ingredients water, alcohol 21.6%, sorbitol, poloxamer 407, benzoic acid, zinc chloride, sodium benzoate, sucralose, flavor, sodium saccharin, blue 1.

Section 51945-4 (51945-4)

COMPARE TO LISTERINE® ULTRACLEAN*

FAMILY wellness™

ULTRA

MOUTHWASH

ANTISEPTIC MOUTHRINSE

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

3.8 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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