NDC Code(s) : 41520-582-12, 41520-582-19
Packager : American Sales

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Care One Fluoride PASTE, DENTIFRICE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-582
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION0.15 g in 100 g
POTASSIUM NITRATE(UNII: RU45X2JN0Z)
(NITRATE ION - UNII:T93E9Y2844) 		POTASSIUM NITRATE5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SODIUM TRIPOLYPHOSPHATE(UNII: 5HK03SA80J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SORBITOL(UNII: 506T60A25R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
GLYCERIN(UNII: PDC6A3C0OX)
XANTHAN GUM(UNII: TTV12P4NEE)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
SODIUM METHYL COCOYL TAURATE(UNII: JVL98CG53G)
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41520-582-191 in 1 CARTON 20/01/2013
1NDC:41520-582-12113 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M022 01/20/2013

LABELER - American Sales(809183973)

REGISTRANT - Lornamead Inc.(080046418)

Establishment
Name Address ID/FEI Business Operations
Lornamead Inc. 080046418 manufacture(41520-582)

PRINCIPAL DISPLAY PANEL

Carton R9