AUTOBRUSH MINT- 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, Xylitol, Alkyl Glucoside, Peg-40 Hydrogenated Caster Oil, Stevia Rebaudiana Extract, LS 95, PVP-K30, Peppermint Flavor, Nano Silver,
Calcium Citrate, Potassium Sorbate, Citric Acid

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Product label

image descriptionimage description

AUTOBRUSH MINT 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82913-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
POVIDONE K30 (UNII: U725QWY32X)  
SILVER (UNII: 3M4G523W1G)  
CALCIUM CITRATE (UNII: MLM29U2X85)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82913-004-011 in 1 CARTON12/01/2022
150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/01/2022
Labeler - Lander Enterprises, LLC (068619221)

Revised: 7/2023
Document Id: 00c78586-02df-4426-e063-6394a90a61a6
Set id: 6bcd35f5-18ea-4fc8-84cd-06db73f38a1e
Version: 2
Effective Time: 20230718
 
Lander Enterprises, LLC