Giant Eagle Wintermint With Fluoride

Manufacturer: Apollo Health and Beauty Care Inc.
Effective date: 2019-10-22
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:01:17

Label at a glance#

ProductGiant Eagle Wintermint With Fluoride

Active ingredientSODIUM FLUORIDE

Label structure7 sections

Indications and uses

aids in the prevention of dental cavities or decay

Dosage and administration

Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste. Vigorously swish 10 mL of rinse between your teeth for 1 minute then spit out. Do not swallow the rinse. Do not eat or dring for 30 mins after rinsing. Instruct children 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision....

Storage and handling

Cold weather may cloud this product, but will not affect its anticavity properties. Store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities or decay

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste. Vigorously swish 10 mL of rinse between your teeth for 1 minute then spit out. Do not swallow the rinse. Do not eat or dring for 30 mins after rinsing.
Instruct children 12 years of age in good rinsing habits (to minimize swallowing).
Supervise children as necessary until capable of using without supervision.
Children under 6 years of age: Consult a dentist or doctor.

Other information

STORAGE AND HANDLING SECTION

Cold weather may cloud this product, but will not affect its anticavity properties.
Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	1
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	1
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	1
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63148-021-33	2021-01-29	C162847	48780-1	ba0f9c33-1fbe-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63148-021-33	Giant Eagle Wintermint With Fluoride	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63148-021	GIANT EAGLE WINTERMINT WITH FLUORIDE (SODIUM FLUORIDE) MOUTHWASH [APOLLO HEALTH AND BEAUTY CARE INC.]	1	Legacy NDC, 1 package rows	20191023_12bf15ed-bc57-48bc-ba02-b8518a77425b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

Giant Eagle Wintermint With Fluoride
Sodium Fluoride
FLUORIDE ION
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
SODIUM LAURYL SULFATE
EUCALYPTOL
METHYL SALICYLATE
THYMOL
PHOSPHORIC ACID
SUCRALOSE
MENTHOL
SODIUM PHOSPHATE DIBASIC DIHYDRATE
FD&C RED NO. 40
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63148-021	63148-021-33

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
SORBITOL	506T60A25R	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
EUCALYPTOL	RV6J6604TK	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
THYMOL	3J50XA376E	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
MENTHOL	L7T10EIP3A	IACT
SODIUM PHOSPHATE DIBASIC DIHYDRATE	94255I6E2T	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0e693b06-4a33-42e1-9cd0-d96521aaf12b			12bf15ed-bc57-48bc-ba02-b8518a77425b	2019-10-22	Warnings	Exact identifier spl id: 0e693b06-4a33-42e1-9cd0-d96521aaf12b spl set id: 12bf15ed-bc57-48bc-ba02-b8518a77425b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.