Act Whitening Anticavity Fluoride Mouthwash Gentle Mint

Act Whitening Anticavity Fluoride Mouthwash Gentle Mint
SPL v4
SPL
SPL Set ID cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49
Route
TOPICAL
Published
Effective Date 2024-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.09 mg)
Inactive Ingredients
Water Glycerin Xylitol Hydrogen Peroxide Poloxamer 407 Propylene Glycol Pentylene Glycol Sodium Benzoate Sodium Phosphate Sodium Phosphate, Dibasic, Anhydrous 4-tert-butylcyclohexanol Menthol Sucralose Saccharin Sodium Edetate Calcium Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-01

Description

ACT Whitening Anticavity Gentle Mint   Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

ACT Whitening Anticavity Gentle Mint   Drug Facts

Use

aids in the prevention of dental cavities  

Active

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Section 42229-5

ACT Whitening

Anticavity Gentle Mint  

Drug Facts

Directions

a dults and children 12 years of age and older:

■ use twice a day after brushing your teeth with a toothpaste  

■ vigorously swish 10 milliliters (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

■ supervise children as necessary until capable of using without supervision

c hildren under 12 years of age: consult a dentist or doctor

Other Information

■ do not use if safety seal is broken or missing

Inactive Ingredients

water, glycerin, xylitol, hydrogen peroxide, poloxamer 407, propylene glycol, pentylene glycol, flavors, sodium benzoate, sodium phosphate, disodium phosphate, 4-t-butylcyclohexanol, menthol, sucralose, sodium saccharin, calcium disodium EDTA

Principal Display Panel

ACT

WHITENING

ANTICAVITY FLUORIDE MOUTHWASH

GENTLE MINT

16.9 fl oz (500 mL)

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.

Stop Use and Ask A Dentist If

oral irritation or tooth sensitivity occurs


Structured Label Content

Use

aids in the prevention of dental cavities  

Active

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Section 42229-5 (42229-5)

ACT Whitening

Anticavity Gentle Mint  

Drug Facts

Purpose

Anticavity

Directions

a dults and children 12 years of age and older:

■ use twice a day after brushing your teeth with a toothpaste  

■ vigorously swish 10 milliliters (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

■ supervise children as necessary until capable of using without supervision

c hildren under 12 years of age: consult a dentist or doctor

Other Information (Other information)

■ do not use if safety seal is broken or missing

Inactive Ingredients (Inactive ingredients)

water, glycerin, xylitol, hydrogen peroxide, poloxamer 407, propylene glycol, pentylene glycol, flavors, sodium benzoate, sodium phosphate, disodium phosphate, 4-t-butylcyclohexanol, menthol, sucralose, sodium saccharin, calcium disodium EDTA

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ACT

WHITENING

ANTICAVITY FLUORIDE MOUTHWASH

GENTLE MINT

16.9 fl oz (500 mL)

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.

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

oral irritation or tooth sensitivity occurs


Advanced Ingredient Data


Raw Label Data

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