SUDS HAND SANITIZER- benzealkonium chloride liquid

SUDS Hand Sanitizer by

Drug Labeling and Warnings

SUDS Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Pro Chem, Inc., ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Box OTC-Active Ingredient Section

benzalkonium chloride USP 0.13%

Drug Facts Box OTC-Indications & Usage Section

For hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box-OTC When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box-OTC Stop Use Section

irritation and redness develop

Drug Facts Box-OTC Keep Out Of Reach Of Children Section

If swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box-OTC Dosage & Administration Section

press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

rub hands together until dry

wash hands with soap and water at earliest opportunity

Drug Facts Box-OTC Inactive Ingredient Section

water, glycerine, dimethicone, DMDM hydantoin, iodopropynl butylcarbamate, methylchloroisothiazolinone, methylisothiazolinone, fragrance

SUDS Hand Sanitizer

SUDS Hand Sanitizer

INGREDIENTS AND APPEARANCE

SUDS HAND SANITIZER 
benzealkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63830-457
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)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63830-457-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	08/12/2019
2	NDC: 63830-457-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/12/2019
3	NDC: 63830-457-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/12/2019
4	NDC: 63830-457-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	08/12/2019
5	NDC: 63830-457-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/12/2019

Labeler - Pro Chem, Inc. (061396065)

Registrant - ABC Compounding Co., Inc. (003284353)

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(63830-457)