NDC Code(s) : 10237-636-60, 10237-636-55
Packager : Church & Dwight Co., Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AIM Whitening Sodium Fluoride GEL, DENTIFRICE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-636
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)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color GREEN Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10237-636-601 in 1 CARTON 08/01/2015
1170 g in 1 TUBE Type 0: Not a Combination Product
2NDC:10237-636-551 in 1 CARTON 08/01/2015
2156 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 07/14/2004

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

PRINCIPAL DISPLAY PANEL

TAKE AIM AGAINST CAVITIES





AIM

Whitening With Baking Soda





Fresh Mint

Gel

NET WT. 6 OZ. (170g)

Anticavity Fluoride Gel Toothpaste

MULTI-BENEFIT

Cleans Freshens Protects

AMFC-00090-01