AIROCARE- sodium fluoride liquid 
Pharmacal-International Co., Ltd

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 0.02%

Purpose

Anticavity mouthwash

Warings

Do not swallow. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Uses

Aids in prevention of dental cavities. Use twice a day after brushing, meals, and before social occasions.

Directions

Rinse mouth with this AIROCARE about 10~15ml for 30 seconds then expel.

Inactive ingredients

Water,Glycerin,Allantoin,Acetic acid,Xylitol,Sodium acetate,Sodium Benzoate,GreenTea Extract,Malic acid,L-Menthol,Propolis Extract,Citrus flavoring,Lemon flavoring,Sodium Saccharin,Lemon Oil,Cacao Color

Keep out of reach of children

Children under 7 years or younger must have parent supervision.

Product label

image descriptionimage description

AIROCARE 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-130
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
ACETIC ACID (UNII: Q40Q9N063P)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MALIC ACID (UNII: 817L1N4CKP)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
LEMON OIL (UNII: I9GRO824LL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24765-130-0114 in 1 BOX02/04/202107/31/2023
111 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/04/202107/31/2023
Labeler - Pharmacal-International Co., Ltd (557805060)
Establishment
NameAddressID/FEIBusiness Operations
Ecoworld Co., Ltd688735061manufacture(24765-130)

Revised: 8/2023
Document Id: 021e3204-8e09-49f7-e063-6394a90a87cc
Set id: 4ce4c8e6-573a-40c9-966c-edbd0d0e0ae2
Version: 3
Effective Time: 20230804
 
Pharmacal-International Co., Ltd