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NDC 63830-0457-12 SUDS Hand Sanitizer 1.3 mg/mL Details

SUDS Hand Sanitizer 1.3 mg/mL

SUDS Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Pro Chem, Inc.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	63830-0457
Product ID	63830-457_f210a3ee-1ad5-4832-ae44-b74d14a26a07
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SUDS Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZEALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Pro Chem, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63830-0457-12 (63830045712)

Pricing Information	N/A
NDC Package Code	63830-457-12
Billing NDC	63830045712
Package	1000 mL in 1 BAG (63830-457-12)
Marketing Start Date	2019-08-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 255a7864-e20d-43b1-b0bc-2362c984f359 Details

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

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

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/12/2019

Labeler - Pro Chem, Inc. (061396065)

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

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

Revised: 8/2019

Document Id: f210a3ee-1ad5-4832-ae44-b74d14a26a07

Set id: 255a7864-e20d-43b1-b0bc-2362c984f359

Version: 1

Effective Time: 20190812