NDC Code(s) : 10237-633-60, 10237-633-72, 10237-633-22, 10237-633-55, 10237-633-66, 10237-633-45
Packager : Church & Dwight Co., Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AIM CAVITY PROTECTION Sodium Fluoride GEL, DENTIFRICE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-633
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
WATER(UNII: 059QF0KO0R)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
PEG-8 STEARATE(UNII: 2P9L47VI5E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
ALCOHOL(UNII: 3K9958V90M)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
SORBITOL(UNII: 506T60A25R)
Product Characteristics
Color green Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10237-633-601 in 1 CARTON 08/01/2015
1170 g in 1 TUBE Type 0: Not a Combination Product
2NDC:10237-633-721 in 1 CARTON 08/01/2015
2204 g in 1 TUBE Type 0: Not a Combination Product
3NDC:10237-633-221 in 1 CARTON 08/01/2015
362 g in 1 TUBE Type 0: Not a Combination Product
4NDC:10237-633-551 in 1 CARTON 08/01/2015
4156 g in 1 TUBE Type 0: Not a Combination Product
5NDC:10237-633-661 in 1 CARTON 08/01/2015
5187 g in 1 TUBE Type 0: Not a Combination Product
6NDC:10237-633-451 in 1 CARTON 28/02/2022
6127 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(10237-633)

PRINCIPAL DISPLAY PANEL

Value Pack

20%

MORE

Product

on sizes up to 4.6 oz.

ADA

Accepted

American

Dental

Association

TAKE AIM AGAINST CAVITIES

Aim

CAVITY PROTECTION

Ultra Mint

Gel

MULTI-BENEFIT

Cleans

Freshens

Protects

Anticavity Fluoride Gel Toothpaste

NET WT. 5.5 OZ. (156g)

AMFC-00093-01_70505178_DA1081102