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NDC 59110-0082-40 QSC TF Ambre Antibacterial Wash 0.003 mg/mL Details

QSC TF Ambre Antibacterial Wash 0.003 mg/mL

QSC TF Ambre Antibacterial Wash is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Triple S a.k.a Standardized Sanitation Systems, Inc. The primary component is CHLOROXYLENOL.

Product Information

NDC	59110-0082
Product ID	59110-082_776c389a-fe26-4d25-bc89-363972b089dd
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	QSC TF Ambre Antibacterial Wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chloroxylenol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.003
Active Ingredient Units	mg/mL
Substance Name	CHLOROXYLENOL
Labeler Name	Triple S a.k.a Standardized Sanitation Systems, 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 59110-0082-40 (59110008240)

Pricing Information	N/A
NDC Package Code	59110-082-40
Billing NDC	59110008240
Package	1200 mL in 1 PACKAGE (59110-082-40)
Marketing Start Date	2008-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8f6f201a-3c4c-4de3-8716-5b2c61654580 Details

Active ingredient

Chloroxylenol 0.3%

Purpose

Antimicrobial

Uses

Handwash to help decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands
Apply a small amount of product and work into a lather
Rinse well and dry hands completely

Inactive ingredients

Water (Aqua), Alcohol, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Propylene Glycol, Ammonium Xylenesulfonate, Cocamide MEA, Glycerin, Isopropyl Alcohol, Lactic Acid, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Ammonium Sulfate, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 6 (CI 15985)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QSC TF AMBRE ANTIBACTERIAL WASH

chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59110-082
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.003 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTIC ACID (UNII: 33X04XA5AT)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
JOJOBA OIL (UNII: 724GKU717M)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CORN OIL (UNII: 8470G57WFM)
AMMONIUM SULFATE (UNII: SU46BAM238)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59110-082-40	1200 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/01/2008

Labeler - Triple S a.k.a Standardized Sanitation Systems, Inc (001968296)

Revised: 11/2016

Document Id: 776c389a-fe26-4d25-bc89-363972b089dd

Set id: 8f6f201a-3c4c-4de3-8716-5b2c61654580

Version: 1

Effective Time: 20161115