Rexall 971.001/971ab

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.1 mg)

Inactive Ingredients

Water Sorbitol Propylene Glycol Poloxamer 407 Sodium Lauryl Sulfate Sodium Benzoate Phosphoric Acid Eucalyptol Methyl Salicylate Thymol Saccharin Sodium Menthol, Unspecified Form Sodium Phosphate, Dibasic, Anhydrous Sucralose Spearmint Oil Peppermint Oil Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-10-01

Medication Information

Purpose

Anticavity

Description

Sealed with printed neckband for your protection.

Use

aids in the prevention of dental cavities

Warning

for this product

Directions

Adults and children 6 years of age and older:

use twice daily after brushing your teeth with a toothpaste
vigorously swish 10 mL of rinse between your teeth for 1 miute 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

Disclaimer

Since 1903 Rexall ^®is a registered trademark of Rexall Sundown, Inc.

*This product is not intended to replace brushing or flossing

Adverse Reaction

100% Satisfaction Guaranteed

If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.

(888)309-9030

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Other Information

store at room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ F)
cold weather may temporarily cloud this product

Inactive Ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Principal Panel Display

Since 1903

Rexall™

Fluoride Anti-Cavity

Mouthwash

Sodium Fluoride and Acidulated

Phosphate Topical Solution

Alcohol-Free

6 BENEFITS

Freshens breath
Restores enamel
Helps strengthen teeth to fight cavities
Kills bad breath germs
Burn free
Cleans the entire mouth*

IMPORTANT: read directions for proper use.

FRESH MINT

1 L (1.05 QT) 33.8 FL OZ

Tamper Evident Statement

Sealed with printed neckband for your protection.

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

Purpose

Anticavity

Warning

for this product

Directions

Adults and children 6 years of age and older:

use twice daily after brushing your teeth with a toothpaste
vigorously swish 10 mL of rinse between your teeth for 1 miute 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

Disclaimer

Since 1903 Rexall ^®is a registered trademark of Rexall Sundown, Inc.

*This product is not intended to replace brushing or flossing

Adverse Reaction

100% Satisfaction Guaranteed

If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.

(888)309-9030

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Other Information (Other information)

store at room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ F)
cold weather may temporarily cloud this product

Inactive Ingredients (Inactive ingredients)

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Principal Panel Display (principal panel display)

Since 1903

Rexall™

Fluoride Anti-Cavity

Mouthwash

Sodium Fluoride and Acidulated

Phosphate Topical Solution

Alcohol-Free

6 BENEFITS

Freshens breath
Restores enamel
Helps strengthen teeth to fight cavities
Kills bad breath germs
Burn free
Cleans the entire mouth*

IMPORTANT: read directions for proper use.

FRESH MINT

1 L (1.05 QT) 33.8 FL OZ

Tamper Evident Statement (TAMPER EVIDENT STATEMENT)

Sealed with printed neckband for your protection.

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

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTOL", "unii": "RV6J6604TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYL SALICYLATE", "unii": "LAV5U5022Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "THYMOL", "unii": "3J50XA376E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SPEARMINT OIL", "unii": "C3M81465G5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "Purpose": "Anticavity ", "Warning": "for this product", "Directions": "Adults and children 6 years of age and older: use twice daily after brushing your teeth with a toothpaste vigorously swish 10 mL of rinse between your teeth for 1 miute 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", "Disclaimer": "Since 1903 Rexall ® is a registered trademark of Rexall Sundown, Inc. *This product is not intended to replace brushing or flossing", "Adverse Reaction": "100% Satisfaction Guaranteed If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied. (888)309-9030 DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072", "Active Ingredient": "Sodium fluoride 0.02% (0.01% w/v fluoride ion)", "Other information": "store at room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ F) cold weather may temporarily cloud this product", "Inactive ingredients": "water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1", "principal panel display": "Since 1903 Rexall™ Fluoride Anti-Cavity Mouthwash Sodium Fluoride and Acidulated Phosphate Topical Solution Alcohol-Free 6 BENEFITS Freshens breath Restores enamel Helps strengthen teeth to fight cavities Kills bad breath germs Burn free Cleans the entire mouth* IMPORTANT: read directions for proper use. FRESH MINT 1 L (1.05 QT) 33.8 FL OZ", "TAMPER EVIDENT STATEMENT": "Sealed with printed neckband for your protection.", "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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information