EMMI DENT SODIUM FLUORIDE ANTICAVITY MILD- sodium fluoride paste, dentifrice
EMAG AG

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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emmi dent Sodium Fluoride Anticavity Toothpaste

emmi dent Sodium Fluoride Anticavity Toothpaste Mild

Active Ingredient

Sodium fluoride 0.243% (0.16 w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
Supervise children as necessary until capable of using without supervision.
Children under 2 years: Consult a dentist or doctor.

Inactive Ingredients

water, hydrated silica, sorbitol, propylene glycol, tetrapotassium pyrophosphate, xanthan, gum, sodium C14-16 olefin sulfonate, flavor, titanium dioxide, sodium methylparaben, sodium saccharin, allantoin, limonene, chamomile (chamomilla recutita) flower extract, three-lobe sage (salvia triloba) leaf extract, citral

Representative Labeling

EMMI DENT SODIUM FLUORIDE ANTICAVITY MILD
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63956-001
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.16 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ALLANTOIN (UNII: 344S277G0Z)
LIMONEN-10-OL, (+)- (UNII: 1Q8KVB0R3J)
CHAMOMILE (UNII: FGL3685T2X)
THREE-LOBE SAGE (UNII: 3V97D33N0K)
CITRAL (UNII: T7EU0O9VPP)

#	Item Code	Package Description
Packaging
1	NDC:63956-001-90	1 in 1 PACKAGE
1		90.6 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	04/22/2014

Labeler - EMAG AG (343617614)

Registrant - EMAG AG (343617614)

Name	Address	ID/FEI	Business Operations
Establishment
EMAG AG		343617614	manufacture(63956-001)