THE HUMBLE CO ANTICAVITY MOUTHWASH FRESH MINT- sodium fluoride rinse 
The Humble Company North America Inc

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The Humble Co Anticavity Mouthwash Fresh Mint

Drug Facts

Active ingredient

Sodium fluride 0.05% (0.02% W/V fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental caries

Warning

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.

Directions

Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters 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. Adults and children 6 years of age and older:

Consult a dentist or doctor. Children under 6 years of age:

Other information

Keep the bottle closed and store in a fresh and dry place. Do not use if carton/case is open.

Inactive ingredients

water, glycerin, betaine, polysorbate-80, peppermint (mentha x piperita l.) oil, flavor, rebaudioside A, lycium (lycium barbarum) fruit extract, green tea (camellia sinensis) extract, asian ginseng (panax ginseng) root extract, aloe vera (aloe barbadensis) leaf juice, citric acid, sodium benzoate, potassium sorbate, limonene

Package Labeling:

Bottle2

THE HUMBLE CO ANTICAVITY MOUTHWASH FRESH MINT 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72299-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BETAINE (UNII: 3SCV180C9W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
REBAUDIOSIDE A (UNII: B3FUD0528F)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72299-011-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02112/01/2019
Labeler - The Humble Company North America Inc (010966342)

Revised: 10/2023
Document Id: 08aaa759-3e7f-ec9c-e063-6294a90a4719
Set id: 75c6474f-29aa-4001-8a07-96794e9f0393
Version: 3
Effective Time: 20231026
 
The Humble Company North America Inc