AIROCARE by Pharmacal-International Co., Ltd / Ecoworld Co., Ltd

AIROCARE by

Drug Labeling and Warnings

AIROCARE by is a Otc medication manufactured, distributed, or labeled by Pharmacal-International Co., Ltd, Ecoworld Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

AIROCARE 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24765-130
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24765-130-01	14 in 1 BOX	02/04/2021	07/31/2023
1		11 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/04/2021	07/31/2023

Labeler - Pharmacal-International Co., Ltd (557805060)

Establishment
Name	Address	ID/FEI	Business Operations
Ecoworld Co., Ltd		688735061	manufacture(24765-130)

Revised: 8/2023

Document Id: 021e3204-8e09-49f7-e063-6394a90a87cc

34390-5

Set id: 4ce4c8e6-573a-40c9-966c-edbd0d0e0ae2

Version: 3

Effective Time: 20230804