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NDC 16496-0544-14 Antiseptic Hand 3 mg/mL Details

Antiseptic Hand 3 mg/mL

Antiseptic Hand is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Image Supply, Inc.. The primary component is CHLOROXYLENOL.

Product Information

NDC	16496-0544
Product ID	16496-544_fa50bc01-c31b-4062-a927-e3a412f8f76e
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	Antiseptic Hand
Proprietary Name Suffix	n/a
Non-Proprietary Name	CHLOROXYLENOL
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	3
Active Ingredient Units	mg/mL
Substance Name	CHLOROXYLENOL
Labeler Name	Image Supply, 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 16496-0544-14 (16496054414)

Pricing Information	N/A
NDC Package Code	16496-544-14
Billing NDC	16496054414
Package	3785 mL in 1 BOTTLE, PLASTIC (16496-544-14)
Marketing Start Date	2005-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7edd2630-bd0b-473f-85ab-34c74e8a3a0f Details

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 0.3%

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

water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, DMDM hydantoin, fragrance, FD and C yellow no.5, food red 10

Antiseptic Hand Soap 1 gallon

INGREDIENTS AND APPEARANCE

ANTISEPTIC HAND

chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16496-544
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:16496-544-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/30/2005

Labeler - Image Supply, Inc. (070632435)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(16496-544)

Revised: 12/2018

Document Id: fa50bc01-c31b-4062-a927-e3a412f8f76e

Set id: 7edd2630-bd0b-473f-85ab-34c74e8a3a0f

Version: 2

Effective Time: 20181228