Rite Aid 163.005/163af-ag

Rite Aid 163.005/163af-ag
SPL v14
SPL
SPL Set ID 5a1b11f3-9d6f-4ac1-90f9-a95d4bb35589
Route
ORAL
Published
Effective Date 2025-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Eucalyptol Methyl Salicylate Menthol Phosphoramidic Acid Saccharin Sodium Thymol Sodium Phosphate, Dibasic, Anhydrous Sucralose Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-05-13

Description

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Use

aids in the prevention of dental cavities

Warnings

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 (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
  • instruct children uder 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

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Fresh Mint Anticavity Mouthwash.

Active Ingredient

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Other Information
  • store at controlled room temperature 20°-25° C to (68° - 77°F)
  • cold weather may temporarily cloud this product
Inactive Ingredients

water, alcohol (21.6%), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol,  disodium posphate, sucralose, red 40, blue 1

Principal Display Panel

Sealed With Printed Neckband For Your Protection

IMPORTANT: READ DIRECTIONS FOR PROPER USE

Compare to Listerine Total Care Anticavity Mouthwash*

Anticavity

Fluoride

Rinse

ANTICAVITY FLUORIDE MOUTHWASH

EUCALYPTUS MINT

restores minerals to enamel

kills bad breath germs

helps prevent cavities

sugar free

1 L (1 QT 1.8 FL OZ) 33.8 FL OZ

Adverse Reaction Section

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION GUARANTEE

If you're not satisfied, we'll happily refund your money.

DSP-TN-21091

DSP-MO-20087

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

Warnings

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 (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
  • instruct children uder 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

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care Fresh Mint Anticavity Mouthwash.

Active Ingredient (Active ingredient)

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Other Information (Other information)
  • store at controlled room temperature 20°-25° C to (68° - 77°F)
  • cold weather may temporarily cloud this product
Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6%), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol,  disodium posphate, sucralose, red 40, blue 1

Principal Display Panel (principal display panel)

Sealed With Printed Neckband For Your Protection

IMPORTANT: READ DIRECTIONS FOR PROPER USE

Compare to Listerine Total Care Anticavity Mouthwash*

Anticavity

Fluoride

Rinse

ANTICAVITY FLUORIDE MOUTHWASH

EUCALYPTUS MINT

restores minerals to enamel

kills bad breath germs

helps prevent cavities

sugar free

1 L (1 QT 1.8 FL OZ) 33.8 FL OZ

Adverse Reaction Section (Adverse reaction section)

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION GUARANTEE

If you're not satisfied, we'll happily refund your money.

DSP-TN-21091

DSP-MO-20087

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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