Rite Aid 581.000/581aa-ab

Rite Aid 581.000/581aa-ab
SPL v12
SPL
SPL Set ID 87356f76-4f5c-4834-9ad3-2e49bc227129
Route
ORAL
Published
Effective Date 2025-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-04

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

Use

Aids in the prevention of dental cavities

Claims

OUR PROMISE:

Gluten Free

Sugar Free

Paraben Free

Warnings

For this product

Directions

Adults and children 6 years of age and older:

  • use twice a day 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 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

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Restoring Anticavity Fluoride Mouthwash Cool Mint.

Adverse Reaction

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMPHILL, PA 17011

www.riteaid.com

SATISFACTION GUARANTEE

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

DSP-TN-21091

DSP-MO-20087

Active Ingredient

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

Inactive Ingredients

water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

Principal Display Panel

Sealed with printed neckband for your protection

IMPORTANT: read directions for proper use.

Compare to Act Restoring Anticavity Fluoride Mouthwash*

FREE FROM

GLUTEN FREE

SUGAR FREE

RESTORING 

ANTICAVITY FLUORIDE 

MOUTHWASH

REFRESHING MINT

restores enamel

helps avoid tooth decay

helps remineralize soft spots

freshens breath

33.8 FL OZ (1 L)

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

Claims

OUR PROMISE:

Gluten Free

Sugar Free

Paraben Free

Purpose

Anticavity

Warnings

For this product

Directions

Adults and children 6 years of age and older:

  • use twice a day 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 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

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Restoring Anticavity Fluoride Mouthwash Cool Mint.

Adverse Reaction

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMPHILL, PA 17011

www.riteaid.com

SATISFACTION GUARANTEE

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

DSP-TN-21091

DSP-MO-20087

Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

Principal Display Panel (principal display panel)

Sealed with printed neckband for your protection

IMPORTANT: read directions for proper use.

Compare to Act Restoring Anticavity Fluoride Mouthwash*

FREE FROM

GLUTEN FREE

SUGAR FREE

RESTORING 

ANTICAVITY FLUORIDE 

MOUTHWASH

REFRESHING MINT

restores enamel

helps avoid tooth decay

helps remineralize soft spots

freshens breath

33.8 FL OZ (1 L)

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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