AUTOBRUSH STRAWBERRY- sodium fluoride liquid
Lander Enterprises, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Sodium Fluoride 0.24%

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing
is accidentally swallowed, get medical help or contact a Poison Control Central right away.

Directions

● Adults and children 2 years of age and older: Brush teeth thoroughly, preferably
after each meal or at least twice per day, or as directed by a dentist or physician.
● Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
● Shake before use.
● Squirt two times into your mouth and start brushing.
● Supervise children as necessary until capable of using without supervision.
● Children under 2 years of age: consult a dentist or physician.

Inactive Ingredients

Aqua, Glycerin, Sorbitol, Poloxamer, Xylitol, Natural Strawberry Flavor, Nano Silver, Potassium Sorbate, Stevioside, Citric Acid, Calcium Citrate

● Questions?

● Email Support: customercare@autobrush.com
● Phone Support: 1-888-468-7404

Product label

image description

AUTOBRUSH STRAWBERRY
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82913-002
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
XYLITOL (UNII: VCQ006KQ1E)
SILVER (UNII: 3M4G523W1G)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STEVIOSIDE (UNII: 0YON5MXJ9P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CALCIUM CITRATE (UNII: MLM29U2X85)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82913-002-01	1 in 1 CARTON	08/01/2022
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/01/2022

Labeler - Lander Enterprises, LLC (068619221)

Revised: 8/2022

Document Id: e533a231-531b-019e-e053-2a95a90a4581

Set id: 05929148-bffe-439f-a9d4-3170816c0fa2

Version: 2

Effective Time: 20220801

Lander Enterprises, LLC