Plaque Refresh Remineralizing Rinse Fresh Mint

Plaque Refresh Remineralizing Rinse Fresh Mint
SPL v4
SPL
SPL Set ID bc1f90da-468c-43aa-b639-fb457070f42f
Route
TOPICAL
Published
Effective Date 2022-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Aloe Vera Leaf Water Sorbitol Glycerin Xylitol Polysorbate 20 Sodium Bicarbonate Avocado Oil .alpha.-tocopherol Acetate Spearmint Oil Peppermint Oil Tea Tree Oil Grapefruit Seed Oil Eucalyptus Oil Menthol Thymol Methyl Salicylate Bixa Orellana Seed Povidone, Unspecified Calcium Lactate Sodium Pyrophosphate Hexasodium Hexametaphosphate Sodium Polymetaphosphate Fd&c Blue No. 1 Zinc Citrate Sodium Benzoate Sodium Gluconate Phosphoric Acid Carboxymethylcellulose Sodium, Unspecified Edetate Disodium Anhydrous Poloxamer 407

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-01-01 Until 2026-09-09

Description

Sodium Fluoride 0.02% (0.01% w/v Fluoride Ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.02% (0.01% w/v Fluoride Ion)

Use

Aids in the prevention of dental cavities

Directions

- Adults and children 12 years of age or older:

- use twice daily after brushing your teeth

- 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

- supervise children as necessary

- Children under 12 year of age: consult a dentist or doctor

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v Fluoride Ion)

Other Information

- store at room temperature

- cold weather may temporarily cloud this product

Package Labeling:

Inactive Ingredients

Water, sorbitol, vegetable glycerin, xylitol, poloxamer-407, polysorbate-20, sodium bicarbonate (baking soda), aloe barbadensis leaf juice extract, persea gratissima (avocado) oil, tocopherol acetate (natural vitamin E), mentha viridis (spearmint) leaf oil, mentha piperita (peppermint) oil, melaleuca alternifolia (tea tree) leaf oil, citrus paradisi (grapefruit) seed oil, eucalyptus globulus leaf oil, menthol, thymol, gaultheria procumbens (wintergreen) leaf oil, bixa orellana (annatto) seed extract, PVP, calcium lactate, tetrasodium pyrophosphate, sodium  hexametaphosphate, blue no.1, zinc citrate, sodium benzoate, sodium gluconate, phosphoric acid, cellulose gum, disodium EDTA.

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

Directions

- Adults and children 12 years of age or older:

- use twice daily after brushing your teeth

- 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

- supervise children as necessary

- Children under 12 year of age: consult a dentist or doctor

Active Ingredient (Active ingredient)

Sodium Fluoride 0.02% (0.01% w/v Fluoride Ion)

Other Information (Other information)

- store at room temperature

- cold weather may temporarily cloud this product

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Water, sorbitol, vegetable glycerin, xylitol, poloxamer-407, polysorbate-20, sodium bicarbonate (baking soda), aloe barbadensis leaf juice extract, persea gratissima (avocado) oil, tocopherol acetate (natural vitamin E), mentha viridis (spearmint) leaf oil, mentha piperita (peppermint) oil, melaleuca alternifolia (tea tree) leaf oil, citrus paradisi (grapefruit) seed oil, eucalyptus globulus leaf oil, menthol, thymol, gaultheria procumbens (wintergreen) leaf oil, bixa orellana (annatto) seed extract, PVP, calcium lactate, tetrasodium pyrophosphate, sodium  hexametaphosphate, blue no.1, zinc citrate, sodium benzoate, sodium gluconate, phosphoric acid, cellulose gum, disodium EDTA.

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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