SKYLINE HERBALS- sodium monofluorophosphate paste, dentifrice

SKYLINE HERBALS by

Drug Labeling and Warnings

SKYLINE HERBALS by is a Otc medication manufactured, distributed, or labeled by SKYLINE HERBALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

Purpose

Anticavity Toothpaste

Use

aids in the prevention of dental cavities

Warning

• Keep out of reach of children under 6 years of age

Warning

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

Directions

• 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

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

Inactive Ingredients

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

INGREDIENTS AND APPEARANCE

SKYLINE HERBALS 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80239-9138
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80239-9138-6	43 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/23/2019

Labeler - SKYLINE HERBALS PRIVATE LIMITED (877566114)