Act Anticavity Fluoride Rinse Kids Groovy Grape

Act Anticavity Fluoride Rinse Kids Groovy Grape
SPL v6
SPL
SPL Set ID cd167c0b-2086-4204-b0ac-90df404bd4bb
Route
TOPICAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Sodium Phosphate, Dibasic, Anhydrous Benzyl Alcohol Fd&c Blue No. 1 Edetate Calcium Disodium Anhydrous Cetylpyridinium Chloride Poloxamer 407 Polysorbate 20 Potassium Sorbate Propylene Glycol D&c Red No. 33 Sodium Benzoate Sodium Phosphate Sorbitol Sucralose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-01

Description

ACT Anticavity Kids Rinse Groovy Grape   0.05% Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

ACT Anticavity Kids Rinse Groovy Grape   0.05% Drug Facts

Use

aids in the prevention of dental cavities  

Active

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Section 42229-5

ACT

Anticavity Kids Rinse Groovy Grape   0.05%

Drug Facts

Principal

ACT

Kids

ANTICAVITY

FLUORIDE RINSE

GROOVY GRAPE

16.9 fl oz (500 mL)

Directions

adults and children 6 years of age and older:

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

■ remove cap

■ hold bottle upright and squeeze. Fill to FILL LINE.

■ pour out. Only the correct 10 milliliters dose will pour out.

■ vigorously swish 10 milliliters 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

■ instruct children under 12 years of age in good rinsing habits (to minimize swallowing)

■ supervise children as necessary until capable of using without supervision

children under 6 years of age: consult a dentist or doctor

Other Information

■ do not use if safety seal is broken or missing

Inactive Ingredients

benzyl alcohol, blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, red 33, sodium benzoate, sodium phosphate, sorbitol, sucralose, water

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

aids in the prevention of dental cavities  

Active

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Section 42229-5 (42229-5)

ACT

Anticavity Kids Rinse Groovy Grape   0.05%

Drug Facts

Purpose

Anticavity

Principal (PRINCIPAL)

ACT

Kids

ANTICAVITY

FLUORIDE RINSE

GROOVY GRAPE

16.9 fl oz (500 mL)

Directions

adults and children 6 years of age and older:

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

■ remove cap

■ hold bottle upright and squeeze. Fill to FILL LINE.

■ pour out. Only the correct 10 milliliters dose will pour out.

■ vigorously swish 10 milliliters 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

■ instruct children under 12 years of age in good rinsing habits (to minimize swallowing)

■ supervise children as necessary until capable of using without supervision

children under 6 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)

benzyl alcohol, blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, red 33, sodium benzoate, sodium phosphate, sorbitol, sucralose, water

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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