Equaline 213.001/213ae Rev 2

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.2 mg)

Inactive Ingredients

Water Sorbitol Menthol Methyl Salicylate Cetylpyridinium Chloride Saccharin Sodium Poloxamer 407 Polysorbate 20 Propylene Glycol Sodium Phosphate Sodium Phosphate, Dibasic, Anhydrous Edetate Calcium Disodium Anhydrous Edetate Disodium Anhydrous Sodium Benzoate Potassium Sorbate Benzyl Alcohol Fd&c Green No. 3 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2009-05-14

Medication Information

Purpose

Anticavity rinse

Description

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

Use

aids in the prevention of dental cavities

Warning

for this product

Directions

adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
remove cap
pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark
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

Adverse Reaction

Sealed with printed neckband for your protection

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ^®Anticavity Fluoride Rinse.

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

Active Ingredient

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

Other Information

store at room temperature

Inactve Ingredients

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Principal Panel Display

NDC 41163-213-44

comapre to Act ^®Anticavity Fluoride Rinse active ingredient*

EQUALINE ^®

anticavity

fluoride

rinse

does not contain ethyl alcohol
helps prevent cavities
helps strengthen teeth
freshens breath

mint

INPORTANT: READ DIRECTIONS FOR PROPER USE.

18 FL OZ (532 mL)

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity rinse

Warning

for this product

Directions

adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
remove cap
pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark
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

Adverse Reaction (ADVERSE REACTION)

Sealed with printed neckband for your protection

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ^®Anticavity Fluoride Rinse.

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

Active Ingredient (Active ingredient)

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

Other Information (Other information)

store at room temperature

Inactve Ingredients (Inactve ingredients)

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Principal Panel Display

NDC 41163-213-44

comapre to Act ^®Anticavity Fluoride Rinse active ingredient*

EQUALINE ^®

anticavity

fluoride

rinse

does not contain ethyl alcohol
helps prevent cavities
helps strengthen teeth
freshens breath

mint

INPORTANT: READ DIRECTIONS FOR PROPER USE.

18 FL OZ (532 mL)

Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "Purpose": "Anticavity rinse", "Warning": "for this product", "Directions ": "adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark 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", "ADVERSE REACTION": "Sealed with printed neckband for your protection *This product is not manufactured or distributed by Chattem, Inc., distributor of Act ® Anticavity Fluoride Rinse. Like it or let us make it right. That's our quality promise. 855-423-2630 DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA", "Active ingredient": "Sodium fluoride 0.05% (0.02% w/v fluoride ion)", "Other information": "store at room temperature", "Inactve ingredients": "water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5", "Principal Panel Display": "NDC 41163-213-44 comapre to Act ® Anticavity Fluoride Rinse active ingredient* EQUALINE ® anticavity fluoride rinse does not contain ethyl alcohol helps prevent cavities helps strengthen teeth freshens breath mint INPORTANT: READ DIRECTIONS FOR PROPER USE. 18 FL OZ (532 mL)", "Keep out of reach of children.": "If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information