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NDC 69790-0466-96 Hand Wash 1.3 mg/mL Details

Hand Wash 1.3 mg/mL

Hand Wash is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by ULINE. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	69790-0466
Product ID	69790-466_21d0ab7d-c8c2-40fb-8ef7-b179c0278ac6
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	Hand Wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	ULINE
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69790-0466-96 (69790046696)

Pricing Information	N/A
NDC Package Code	69790-466-96
Billing NDC	69790046696
Package	221 mL in 1 BOTTLE, PLASTIC (69790-466-96)
Marketing Start Date	2016-02-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5a4d6fb7-486a-448c-b379-726adf60e411 Details

Active ingredient

Benzalkonium chloride 0.13%

purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

warnings

For external use only: hands only

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops
condition persists for more than 72 hours

Keep out of reach of children

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

Directions

wet hands
apply palmful to hands
scrub thoroughly
rinse thoroughly

Inactive ingredients

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, fragrance, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, red 4, yellow 5

Adverse reactions

Distributed by: ULINE, 12575 Uline Drive

pleasant Prairie, WI 53158

1-800-295-5510

uline.com

principal Display Panel

ULINE

ANTIBACTERIAL

HAND SOAP

S-20662

7.5 FL OZ (221 mL)

INGREDIENTS AND APPEARANCE

HAND WASH

benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69790-466
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)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SULISOBENZONE (UNII: 1W6L629B4K)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69790-466-96	221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/17/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/17/2016

Labeler - ULINE (039612668)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(69790-466)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(69790-466)

Revised: 8/2022

Document Id: 21d0ab7d-c8c2-40fb-8ef7-b179c0278ac6

Set id: 5a4d6fb7-486a-448c-b379-726adf60e411

Version: 9

Effective Time: 20220808