GIANT EAGLE WINTERMINT WITH FLUORIDE- sodium fluoride mouthwash 
Apollo Health and Beauty Care Inc.

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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Drug Facts

Active ingredient

Sodium Fluoride 0.02% (0.01% w/v Fluoride ion)

Purpose

Anticavity

Uses

aids in the prevention of dental cavities or decay

Warnings

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

Water (Aqua), Alcohol (21.6%), Sorbitol, Poloxamer 407, Sodium Lauryl Sulfate, Eucalyptol, Flavor, Methyl Salicylate, Thymol, Phosphoric Acid, Sucralose, Menthol, Disodium Phosphate, Red 40 (CI 16035), Blue 1 (CI 42090).

Label copy

Image of the label

GIANT EAGLE WINTERMINT WITH FLUORIDE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-021
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
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
THYMOL (UNII: 3J50XA376E)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-021-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/21/2019
Labeler - Apollo Health and Beauty Care Inc. (201901209)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(63148-021)

Revised: 10/2019
Document Id: 0e693b06-4a33-42e1-9cd0-d96521aaf12b
Set id: 12bf15ed-bc57-48bc-ba02-b8518a77425b
Version: 1
Effective Time: 20191022
 
Apollo Health and Beauty Care Inc.