NDC Code(s) : 59555-901-08, 59555-901-04, 59555-901-10, 59555-901-11, 59555-901-13, 59555-901-14, 59555-901-09, 59555-901-16
Packager : R&R Lotion, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

I.C. Hand SanitizerBenzethonium Chloride and Dimethicone LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59555-901
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzethonium Chloride(UNII: PH41D05744)
(Benzethonium - UNII:1VU15B70BP) 		Benzethonium Chloride2 mg in 1 mL
Dimethicone(UNII: 92RU3N3Y1O)
(Dimethicone - UNII:92RU3N3Y1O) 		Dimethicone20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Propylene Glycol(UNII: 6DC9Q167V3)
Stearyl Alcohol(UNII: 2KR89I4H1Y)
cholecalciferol(UNII: 1C6V77QF41)
Cetyl Alcohol(UNII: 936JST6JCN)
vitamin A(UNII: 81G40H8B0T)
Gluconolactone(UNII: WQ29KQ9POT)
Sodium Benzoate(UNII: OJ245FE5EU)
Calcium Gluconate(UNII: SQE6VB453K)
.Alpha.-Tocopherol(UNII: H4N855PNZ1)
Ethylhexyl Palmitate(UNII: 2865993309)
Behentrimonium Methosulfate(UNII: 5SHP745C61)
Cetostearyl Alcohol(UNII: 2DMT128M1S)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59555-901-08236 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:59555-901-0459 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:59555-901-10946 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product
4NDC:59555-901-113785 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product
5NDC:59555-901-1350 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product
6NDC:59555-901-1489 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product
7NDC:59555-901-09473 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
8NDC:59555-901-164 mL in 1 PACKET Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333A 12/21/2015

PRINCIPAL DISPLAY PANEL

R&R
LOTION®

I.C. HAND SANITIZER

FOUR HOUR PROTECTION

8 FL. OZ. (236ML) e

Principal Display Panel - 236 ML Bottle Label