NDC Code(s) : 10237-635-60, 10237-635-61, 10237-635-55
Packager : Church & Dwight Co., Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AIM TARTAR CONTROL Sodium Fluoride GEL, DENTIFRICE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-635
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 ION2.4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL(UNII: 506T60A25R)
WATER(UNII: 059QF0KO0R)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
PEG-8 STEARATE(UNII: 2P9L47VI5E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
ALCOHOL(UNII: 3K9958V90M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(UNII: K679OBS311)
ZINC CITRATE(UNII: K72I3DEX9B)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color blue Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10237-635-601 in 1 CARTON 08/01/2015
1170 g in 1 TUBE Type 0: Not a Combination Product
2NDC:10237-635-611 in 1 CARTON 08/01/2015
2170 g in 1 TUBE Type 0: Not a Combination Product
3NDC:10237-635-551 in 1 CARTON 08/01/2015
3156 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 M021 03/01/2004

LABELER - Church & Dwight Co., Inc.(001211952)

Establishment
Name Address ID/FEI Business Operations
Church & Dwight Co., Inc. 043690812 manufacture(10237-635)

PRINCIPAL DISPLAY PANEL

TAKE AIM AGAINST CAVITIES









AIM





TARTAR CONTROL Plus Mouthwash and Whitening







Cool Mint Gel

NET WT. 6 OZ. (170g)

Anticavity Fluoride Gel Toothpaste

MULTI-BENEFIT

Cleans Freshens Protects





AMFC-00064-01