MOON WHITENING ANTICAVITY- sodium fluoride paste 
Moon Oral Care, LLC

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Directions:

Adults and children 2 years and older:

Brush teeth thoroughly after meals or at least twice a a day or use as direfted by a dentist

Do not swallow to minimize swallowing use a pea-sized amount in children under 6

Supervise children's brushing until good habits are established

Children under 2 years: ask a dentist

Warning:

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 Center right away. Contains sodium fluoride. Children of 6 years and younger: Use a pea-sized amount with supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

Children of 6 years and younger: Use a pea-sized amount with supervised brushing to minimize swallowing.

Sodium Fluoride 0.24% (0.13% w/v fluoride ion) Anticavity

Use: Aids in the prevention of dental cavities

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 Center right away.

WATER

SORBITOL

HYDRATED SILICA

GLYCERIN

XYLITOL

MICA

CELLULOSE GUM

SODIUM LAUROYL SARCOSINATE

TITANIUM DIOXIDE

SACCHARIN SODIUM

CARRAGEENAN

FLAVOR

MENTHA ARVENSIS LEAF OIL

PEPPERMINT OIL

COCONUT OIL

CRANBERRY SEED OIL

TEA TREE OIL

SEA SALT

GREEN TEA LEAF

ECHINACEA ANGUSTIFOLIA LEAF

MYRCIARIA DUBIA FRUIT

ASIAN GINSENG

HYDROGEN PEROXIDE

Tube

Outer

MOON WHITENING ANTICAVITY 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82214-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.23 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
MICA (UNII: V8A1AW0880)  
WATER (UNII: 059QF0KO0R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
TEA TREE OIL (UNII: VIF565UC2G)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SEA SALT (UNII: 87GE52P74G)  
MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
COCONUT OIL (UNII: Q9L0O73W7L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82214-002-021 in 1 CARTON07/01/2019
1NDC:82214-002-01119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02207/01/2019
Labeler - Moon Oral Care, LLC (018021163)

Revised: 12/2023
Document Id: 0bdcad3e-b8ea-bd91-e063-6394a90a666a
Set id: 0bdcad3e-b8e9-bd91-e063-6394a90a666a
Version: 1
Effective Time: 20231206
 
Moon Oral Care, LLC