Giant Eagle Wintermint Zero Alcohol

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 Zero Alcohol

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 drink for 30 minutes after rinsing. Instruct children 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervis...

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 drink for 30 minutes 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), Sorbitol, Propylene Glycol, Poloxamer 407, Sodium Lauryl Sulfate, Flavor, Phosphoric Acid, Eucalyptol, Methyl Salicylate, Thymol, Menthol, Disodium Phosphate, Sucralose, 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
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63148-022-33	2021-01-29	C162847	48780-1	ba0f9c33-2971-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63148-022-33	Giant Eagle Wintermint Zero Alcohol	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
63148-022	GIANT EAGLE WINTERMINT ZERO ALCOHOL (SODIUM FLUORIDE) MOUTHWASH [APOLLO HEALTH AND BEAUTY CARE INC.]	1	Legacy NDC, 1 package rows	20191023_a271e0ff-614b-4b8b-9eec-de82c8c12e4d.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 Zero Alcohol
Sodium Fluoride
FLUORIDE ION
WATER
SORBITOL
PROPYLENE GLYCOL
POLOXAMER 407
SODIUM LAURYL SULFATE
PHOSPHORIC ACID
EUCALYPTOL
METHYL SALICYLATE
THYMOL
MENTHOL
SODIUM PHOSPHATE DIBASIC DIHYDRATE
SUCRALOSE
FD&C RED NO. 40
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63148-022	63148-022-33

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
SORBITOL	506T60A25R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
EUCALYPTOL	RV6J6604TK	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
THYMOL	3J50XA376E	IACT
MENTHOL	L7T10EIP3A	IACT
SODIUM PHOSPHATE DIBASIC DIHYDRATE	94255I6E2T	IACT
SUCRALOSE	96K6UQ3ZD4	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
3ea64bdf-8ff5-4e62-a4cc-2fdbd0a65b85			a271e0ff-614b-4b8b-9eec-de82c8c12e4d	2019-10-22	Warnings	Exact identifier spl id: 3ea64bdf-8ff5-4e62-a4cc-2fdbd0a65b85 spl set id: a271e0ff-614b-4b8b-9eec-de82c8c12e4d

Reported adverse events (FAERS/openFDA)#

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