MEDIAN NEW FOREST- sodium fluoride paste
AMOREPACIFIC CORPORATION

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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MEDIAN New Forest fluoride toothpaste 90g

Drug Facts

ACTIVE INGREDIENTS

SODIUM FLUORIDE 0.22 % (1000 ppm/ 0.1% w/v fluoride ion)

PURPOSE

Anticavity

USE

Aids in the prevention of dental cavities

WARNINGS

Keep out of the 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 of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times 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 of age: Consult a dentist or doctor.

INACTIVE INGREDIENTS

WATER, SORBITOL, HYDRATED SILICA, SODIUM LAURYL SULFATE, CELLULOSE GUM, PEG–32, MENTHOL, METHYLPARABEN, ALCOHOL, SODIUM SACCHARIN, TOCOPHERYL ACETATE, PINUS SYLVESTRIS BUD EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, FRAGRANCE, MICA, TITANIUM DIOXIDE, YELLOW 10 (CI 47005), BLUE 1 (CI 42090)

PRINCIPAL DISPLAY PANEL - 90 g Tube Carton

MEDIAN

f
FRESH
FOREST

Coolsense™

MEDIAN
New Forest fluoride toothpaste 90g

Net Wt. 3.17 oz./90 g

PRINCIPAL DISPLAY PANEL - 90 g Tube Carton

MEDIAN NEW FOREST
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-903
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.198 g in 90 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALCOHOL (UNII: 3K9958V90M)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-903-23	1 in 1 CARTON	03/05/2013	09/20/2018
1		90 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	03/05/2013	09/20/2018

Labeler - AMOREPACIFIC CORPORATION (631035289)

Revised: 10/2018

Document Id: 8263bf92-7a0f-4575-8756-0db261db7438

Set id: 26bd685a-89d2-46c1-b051-9d38adf3e1bf

Version: 2

Effective Time: 20181002

AMOREPACIFIC CORPORATION