Gelato Homecare

Manufacturer: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Effective date: 2024-04-19
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:11:24

Label at a glance#

ProductGelato Homecare

Active ingredientSTANNOUS FLUORIDE

Label structure10 sections

Indications and uses

Home Care is a stable fluoride gel for home use. Aids in the prevention of dental decay.

Dosage and administration

Adults and children 6 years of age and older: Twist off cap to remove foil seal. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize s...

Storage and handling

Store at controlled room temperature 59° - 86°F (15° - 30°C).

Contacts and useful links#

PhoneLabel contact1-800-333-3131

Websitewww.keystoneind.com

www.keystoneind.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride 0.4%

Purpose

OTC - PURPOSE SECTION

Fluoride preventive treatment gel

Uses

INDICATIONS & USAGE SECTION

Home Care is a stable fluoride gel for home use.
Aids in the prevention of dental decay.

WARNINGS SECTION

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

WARNINGS SECTION

This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older: Twist off cap to remove foil seal. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (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

Store at controlled room temperature 59° - 86°F (15° - 30°C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbopol, Flavor, Glycerine, Malic Acid, Sodium Carboxymethylcellulose, Water, Xanthan Gum.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-333-3131 or www.keystoneind.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal display panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
237847	stannous fluoride 0.4 % Oral Gel	PSN	7
237847	stannous fluoride 0.004 MG/MG Oral Gel	SCD	7
237847	stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel	SY	7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68400-201-04	Gelato Homecare	120 g in 1 TUBE	GEL	120		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68400-201	GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	7	Current NDC, Legacy NDC, 1 package rows	20240426_1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Stannous Fluoride	ACTIVE INGREDIENT	3FTR44B32Q	2
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	2
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
Malic Acid	INACTIVE INGREDIENT	817L1N4CKP	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Gelato Homecare
Stannous Fluoride
GLYCERIN
WATER
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
CARBOXYMETHYLCELLULOSE SODIUM
MALIC ACID
XANTHAN GUM
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68400-201	68400-201-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
MALIC ACID	817L1N4CKP	IACT
XANTHAN GUM	TTV12P4NEE	IACT
STANNOUS FLUORIDE	3FTR44B32Q	ACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii+dosage form 12 equally ranked IID candidates
Malic Acid	MALIC ACID	817L1N4CKP	SOLUTION / ORAL		16760 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Malic Acid	MALIC ACID	817L1N4CKP	TABLET / ORAL		20 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Malic Acid	MALIC ACID	817L1N4CKP	SOLUTION / ORAL		16760 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Malic Acid	MALIC ACID	817L1N4CKP	SUSPENSION / ORAL		180 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+dosage form 12 equally ranked IID candidates
Malic Acid	MALIC ACID	817L1N4CKP	POWDER, FOR SUSPENSION / ORAL		1392 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Malic Acid	MALIC ACID	817L1N4CKP	POWDER, FOR SUSPENSION / ORAL		1392 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / OPHTHALMIC	4 %w/w		Exact identifier — unii+dosage form 6 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TRANSDERMAL		150 mg	Exact identifier — unii+dosage form 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii+dosage form 12 equally ranked IID candidates
Malic Acid	MALIC ACID	817L1N4CKP	POWDER, FOR SOLUTION / ORAL		1230 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TOPICAL		85 mg	Exact identifier — unii+dosage form 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii+dosage form 12 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / OPHTHALMIC	4 %w/w		Exact identifier — unii+dosage form 6 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GEL / DENTAL	0.4 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+dosage form 12 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TOPICAL		85 mg	Exact identifier — unii+dosage form 6 equally ranked IID candidates
Malic Acid	MALIC ACID	817L1N4CKP	SUSPENSION / ORAL		180 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii+dosage form 12 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GEL / DENTAL	0.4 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Malic Acid	MALIC ACID	817L1N4CKP	TABLET / ORAL		20 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TRANSDERMAL		150 mg	Exact identifier — unii+dosage form 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
Malic Acid	MALIC ACID	817L1N4CKP	POWDER, FOR SOLUTION / ORAL		1230 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates

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
Gelato Homecare	STANNOUS FLUORIDE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db	2024-04-19	Warnings	Exact identifier ndc (package): 68400-201-04 ndc (product): 68400-201 ndc11 (package): 68400020104 spl id: 1679a47c-dc75-72ca-e063-6294a90a39c0 spl set id: 1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db

Reported adverse events (FAERS/openFDA)#

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