SKYLINE HERBALS

Manufacturer: SKYLINE HERBALS PRIVATE LIMITED
Effective date: 2020-08-31
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:26:27

Label at a glance#

ProductSKYLINE HERBALS

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure9 sections

Dosage and administration

Do not swallow Supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician Children under 6 years of age: Do not use unless directed by a ...

Storage and handling

Store at 59°-86°F (15°-30°C) Avoid excessive heat

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

Warning

WARNINGS SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Do not swallow
Supervise children as necessary until capable of using without supervision
Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
Children under 6 years of age: Do not use unless directed by a dentist or physician

Other Information

STORAGE AND HANDLING SECTION

Store at 59°-86°F (15°-30°C)
Avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Sodium Carboxymethyl Cellulose, Flavor, Sodium Saccharin, Sodium Methyl Paraben, Sodium Propyl Paraben

PRINCIPAL DISPLAY PANEL - 43 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	1
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80239-9138-6	2022-01-28	C162847	48780-1	d6a99b39-45c1-a426-e053-dadaa90af4c2	SKYLINE Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80239-9138-6	SKYLINE HERBALS	43 g in 1 TUBE	PASTE, DENTIFRICE	43		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80239-9138	SKYLINE HERBALS (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [SKYLINE HERBALS PRIVATE LIMITED]	1	Legacy NDC, 1 package rows	20200901_ae30bf18-8b14-1519-e053-2a95a90a5628.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

SKYLINE HERBALS
Sodium Monofluorophosphate
CALCIUM CARBONATE
WATER
SORBITOL
HYDRATED SILICA
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
SACCHARIN SODIUM
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80239-9138	80239-9138-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALCIUM CARBONATE	H0G9379FGK	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	K679OBS311	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
METHYLPARABEN SODIUM	CR6K9C2NHK	IACT
PROPYLPARABEN SODIUM	625NNB0G9N	IACT
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM

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
ae30c235-46b0-65a3-e053-2995a90a7adf			ae30bf18-8b14-1519-e053-2a95a90a5628	2020-08-31	Warnings	Exact identifier spl id: ae30c235-46b0-65a3-e053-2995a90a7adf spl set id: ae30bf18-8b14-1519-e053-2a95a90a5628

Reported adverse events (FAERS/openFDA)#

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