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NDC 42355-0265-19 All Stop Medicated Body Wash 25 mg/mL Details

All Stop Medicated Body Wash 25 mg/mL

All Stop Medicated Body Wash is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Q-Based Solutions Inc. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	42355-0265
Product ID	42355-265_5cca2d96-cc63-4bc3-b226-09978e97c1ea
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	All Stop Medicated Body Wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	25
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Q-Based Solutions 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 42355-0265-19 (42355026519)

Pricing Information	N/A
NDC Package Code	42355-265-19
Billing NDC	42355026519
Package	18900 mL in 1 CONTAINER (42355-265-19)
Marketing Start Date	2017-12-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f97cf4d9-a402-4a43-aaab-b097b9d96124 Details

Drug Facts Box OTC-Active Ingredient Section

Benzalkonium Chloride 2.5%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

For external use only

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

wet hands and forearms
apply 5 milliliters (teaspoonful) or palmful to hands and forearms
scrub thoroughly for 1 minute and rinse

Drug Facts Box OTC-Inactive Ingredient Section

ater, glycerin, isopropyl alcohol, disodium cocoamphodiproprionate, hydroxyethylcellulose, lauramine oxide,

PEG-75 lanolin, citric acid, FD and C red no.4

All Stop Medicated Body Wash 6265 Drug Facts and Label

INGREDIENTS AND APPEARANCE

ALL STOP MEDICATED BODY WASH

benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42355-265
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	25.0 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PEG-75 LANOLIN (UNII: 09179OX7TB)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42355-265-05	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/21/2017
2	NDC:42355-265-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/21/2017
3	NDC:42355-265-19	18900 mL in 1 CONTAINER; Type 0: Not a Combination Product	12/21/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/21/2017

Labeler - Q-Based Solutions Inc (153509315)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(42355-265)

Revised: 7/2019

Document Id: 5cca2d96-cc63-4bc3-b226-09978e97c1ea

Set id: f97cf4d9-a402-4a43-aaab-b097b9d96124

Version: 3

Effective Time: 20190709