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NDC 00404-5990-01 Antimicrobial Hand Wash 6 mg/1000mL Details

Antimicrobial Hand Wash 6 mg/1000mL

Antimicrobial Hand Wash is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Henry Schein, Inc.. The primary component is CHLOROXYLENOL.

Product Information

NDC	00404-5990
Product ID	0404-5990_2175033d-2201-4e33-86ee-600fac438d58
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	Antimicrobial Hand Wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chloroxylenol
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	6
Active Ingredient Units	mg/1000mL
Substance Name	CHLOROXYLENOL
Labeler Name	Henry Schein, Inc.
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 00404-5990-01 (00404599001)

Pricing Information	N/A
NDC Package Code	0404-5990-01
Billing NDC	00404599001
Package	800 mL in 1 BOX (0404-5990-01)
Marketing Start Date	2012-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5847a304-ff8e-4ae1-8bf0-ee7e6efb9451 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Chloroxylenol (PCMX) 0.6%

Purpose

Antiseptic

Uses

for handwashing to decrease bacteria on skin. Recommended for repeated use.

Warnings

For external use only.

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask doctor if

irritation and redness develops and 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 and forearms
apply 5 milliliters (teaspoonful) or palmful to hands and forearms
scrub thoroughly for 30 seconds
supervise children under 6 years of age

Inactive Ingredients

aloe vera, cocamide DEA, cocamidopropyl betaine, D&C Red #33, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

Distributed by HENRY SCHEIN, INC. Melville, NY 11747 USA

Made in U.S.A.

PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label

Henry Schein

112-5990

Maxiclens

Antimicrobial Hand Wash

NDC 0404-5990-01

27.05 FL. OZ. (800 ML)

PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label

INGREDIENTS AND APPEARANCE

ANTIMICROBIAL HAND WASH

chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0404-5990
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q)	chloroxylenol	6.0 mg in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
aloe vera leaf (UNII: ZY81Z83H0X)
coco diethanolamide (UNII: 92005F972D)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
diazolidinyl urea (UNII: H5RIZ3MPW4)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium chloride (UNII: 451W47IQ8X)
sodium laureth sulfate (UNII: BPV390UAP0)
edetate sodium (UNII: MP1J8420LU)
alpha-tocopherol acetate (UNII: 9E8X80D2L0)
propylparaben (UNII: Z8IX2SC1OH)
methylparaben (UNII: A2I8C7HI9T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-5990-01	800 mL in 1 BOX; Type 0: Not a Combination Product	03/01/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/01/2012

Labeler - Henry Schein, Inc. (012430880)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(0404-5990)

Revised: 7/2016

Document Id: 2175033d-2201-4e33-86ee-600fac438d58

Set id: 5847a304-ff8e-4ae1-8bf0-ee7e6efb9451

Version: 2

Effective Time: 20160729