I.C. SANITIZER AND RE-MOISTURIZER WITH BENZALKONIUM CHLORIDE- benzalkonium chloride lotion

I.C. Sanitizer and Re-Moisturizer with Benzalkonium Chloride by

Drug Labeling and Warnings

I.C. Sanitizer and Re-Moisturizer with Benzalkonium Chloride by is a Otc medication manufactured, distributed, or labeled by R & R Lotion, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

Hand Sanitizer to decrease bacteria on the skin persistently. Recommended for repeated use.

Warnings

For external use only

• When using this product, aviod contact with eyes
• In case of eye contact, flush with water

• Keep out of reach of children, except under adult supervision
• If swallowed, get medical help
• Discontinue use if skin irritation or redness develops

Directions

Rub onto hands until absorbed.

Ingredients

Purified Water, Arlacel 165, Incroquat Behenyl TMS, Caprylic/-Capric Triglyceride, Glycerin 99%, Shea Butter, Sunflower Butter, Dimethicone, Floraesters K-20W, Lanette 16, Geogard Ultra, Xanthan Gum, Disodium EDTA, Succulents (Jojoba, Blue Agave, Aloe Vera), Extracts (Acai, Aloe Whole Leaf, Blueberry, Cranberry, Grape Seed, Green Coffee, Green Tea, Pomegranate, Raspberry Fruit & Strawberry), Vitamin A & D, Vitamin E Acetate.

Questions or Comments?

Call (480) 443-9255 or visit RRlotion.com

PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label

HAND CREAM

R&R
LOTION®

I.C. HAND SANITIZER

'ALCOHOL FREE'

8 FL. OZ. (236ML) ℮

INGREDIENTS AND APPEARANCE

I.C. SANITIZER AND RE-MOISTURIZER WITH BENZALKONIUM CHLORIDE 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59555-903
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)
Calcium Gluconate (UNII: SQE6VB453K)
Sodium Benzoate (UNII: OJ245FE5EU)
Gluconolactone (UNII: WQ29KQ9POT)
Behentrimonium Methosulfate (UNII: 5SHP745C61)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl 1-Stearate (UNII: 258491E1RZ)
Dimethicone (UNII: 92RU3N3Y1O)
PEG-100 Stearate (UNII: YD01N1999R)
Cetyl Alcohol (UNII: 936JST6JCN)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Shea Butter (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
Glycerin (UNII: PDC6A3C0OX)
POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
vitamin A (UNII: 81G40H8B0T)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59555-903-03	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/02/2018
2	NDC: 59555-903-04	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/02/2018
3	NDC: 59555-903-09	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/02/2018
4	NDC: 59555-903-08	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	11/02/2018
5	NDC: 59555-903-10	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/02/2018
6	NDC: 59555-903-11	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/02/2018
7	NDC: 59555-903-06	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	12/21/2015

Labeler - R & R Lotion, Inc (062979000)