MedActive Patient Friendly

Manufacturer: Integrate Oral Care, LLC.
Effective date: 2021-12-30
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-05-31 23:46:05

Label at a glance#

ProductMedActive Patient Friendly

Active ingredientSTANNOUS FLUORIDE

Label structure11 sections

Contacts and useful links#

PhoneLabel contact1-866-877-4876

Websitewww.integrateoralcare.com

www.integrateoralcare.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Stannous fluoride 0.1%

OTC - PURPOSE SECTION

Purpose

Cavity protection

INDICATIONS & USAGE SECTION

Uses

Aids in the prevention of dental decay.

WARNINGS SECTION

When using this product, do not use longer than four weeks unless recommended by a medical doctor and/or dental professional.
If more than used for rinsing is swallowed, seek medical attention or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Use immediately after preparing the rinse as follows:

Adults and children 6 years or age and older:

Place both thumbs on Blue Chamber No. 1 and Press down firmly to squeeze fluoride into Chamber No. 2.
Gently Shake.
Snap Tab to Open by bending at line on the cap. Dispense half of mixture into the mouth and Rinse for 30 seconds. Spit.
Gargle with remainder of mixture for 30 seconds. Spit.
Avoid any food or drinks for at least 15 minutes after use.

Children under 6 years of age:

Consult your medical doctor and/or dental professional.

OTHER SAFETY INFORMATION

Other information

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 dental professional.
Do not refrigerate. Store at room temperature.
See Rinse or box for expiration date.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

dimethicone, EDTA, FD&C Green No. 3, flavor (includes Spilanthes Extract), glycerin, poloxamer 407, potassium sorbate, sodium saccharin, sorbitol, sucralose, water

OTC - QUESTIONS SECTION

Questions or comments?

1-866-877-4876 M-F 9am-5pm EST or www.integrateoralcare.com

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Orange Crème with ULTRAMULSION® & Spilanthes ExtractMedActive® Oral Care Redefined _™

Patient-Friendly™ Orange Crème

Stannous Fluoride Rinse with ULTRAMULSION ^® & Spilanthes Extract

10 DOSE PACKS

IMPORTANT

Read directions for proper use.

NET CONTENTS: 10 DOSE PACKS 10.4 FL OZ (307 mL)

NDC 49741-1005-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MedActive® Oral Care Redefined _™

Patient-Friendly™ Orange Crème

Stannous Fluoride Rinse with ULTRAMULSION ^® & Spilanthes Extract

30 DOSE PACKS

IMPORTANT

Read directions for proper use.

NET CONTENTS: 30 DOSE PACKS 31.2 FL OZ (923 mL)

NDC 49741-1005-3

Orange Crème with ULTRAMULSION® & Spilanthes Extract

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1654969	MedActive Oral Relief Rinse 0.1 % Oral Rinse	PSN	12
1654967	stannous fluoride 0.1 % Oral Rinse	PSN	12
583459	stannous fluoride 0.63 % Dental Solution	PSN	12
1654969	stannous fluoride 1 MG/ML Mouthwash [MedActive Rinse]	SBD	12
1654967	stannous fluoride 1 MG/ML Mouthwash	SCD	12
583459	stannous fluoride 6.3 MG/ML Mouthwash	SCD	12
1654969	MedActive Oral Relief Rinse 0.1 % Mouthwash	SY	12
1654969	MedActive Rinse 1 MG/ML Mouthwash	SY	12
583459	stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental Solution	SY	12
583459	stannous fluoride 0.63 % Dental Solution	SY	12

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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
49741-1005-2	2023-01-30	C162847	48780-1	f386c649-b326-0266-e053-dadaa90a7c1a	18bcb094-6257-4d1d-e054-00144ff88e88
49741-1005-3	2023-01-30	C162847	48780-1	f386c649-b326-0266-e053-dadaa90a7c1a	18bcb094-6257-4d1d-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49741-1005-1	MedActive Patient Friendly	1 in 1 CARTON	KIT	1	12
49741-1005-2	MedActive Patient Friendly	10 in 1 BOX	KIT	10	12
49741-1005-3	MedActive Patient Friendly	1 in 1 CARTON	KIT	1	12
49741-1005-3	MedActive Patient Friendly	30 in 1 BOX	KIT	30	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49741-1005	MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [INTEGRATE ORAL CARE, LLC.]	12	Legacy NDC, 4 package rows	20211231_18bcb094-6257-4d1d-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
STANNOUS FLUORIDE	ACTIVE INGREDIENT	3FTR44B32Q	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

MedActive Patient Friendly
Stannous Fluoride
Chamber No. 1
FLUORIDE ION
GLYCERIN
FD&C GREEN NO. 3
Chamber No. 2
Stannous Fluoride Diluent
SACCHARIN SODIUM
SORBITOL
DIMETHICONE
EDETIC ACID
POLOXAMER 407
SUCRALOSE
WATER
POTASSIUM SORBATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49741-1005	49741-1005-1, 49741-1005-2, 49741-1005-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
STANNOUS FLUORIDE	3FTR44B32Q	ACTIM
GLYCERIN	PDC6A3C0OX	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
DIMETHICONE	92RU3N3Y1O	IACT
EDETIC ACID	9G34HU7RV0	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
WATER	059QF0KO0R	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT

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 4 · 237 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE / ORAL	40 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	SOLUTION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / RECTAL	6.67 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	TABLET / ORAL		495 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	TABLET / ORAL		240 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	TABLET / ORAL	4 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SPRAY, METERED / NASAL	0.06 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SHAMPOO / TOPICAL	0.09 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETIC ACID	EDETIC ACID	9G34HU7RV0	INJECTION, SOLUTION / INTRAVENOUS		2 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	SYRUP / ORAL	3.75 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C GREEN NO. 3	FD&C GREEN NO. 3	3P3ONR6O1S	CAPSULE, DELAYED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 15 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
d4645068-90cf-054f-e053-2a95a90a5b96			18bcb094-6257-4d1d-e054-00144ff88e88	2021-12-30	Warnings	Exact identifier spl id: d4645068-90cf-054f-e053-2a95a90a5b96 spl set id: 18bcb094-6257-4d1d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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