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NDC 59110-0052-34 Triple S Gentle Antibacterial Cleanser 0.003 mg/mL Details

Triple S Gentle Antibacterial Cleanser 0.003 mg/mL

Triple S Gentle Antibacterial Cleanser 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	59110-0052
Product ID	59110-052_9e6fe284-1f87-45d1-81da-acb84ef7aacf
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	Triple S Gentle Antibacterial Cleanser
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	n/a

Package

Package Images

NDC 59110-0052-34 (59110005234)

Pricing Information	N/A
NDC Package Code	59110-052-34
Billing NDC	59110005234
Package	1000 mL in 1 PACKAGE (59110-052-34)
Marketing Start Date	2008-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e5992562-633d-4ffc-ae0a-c89385768d02 Details

Active ingredient

Chloroxylenol 0.3%

Purpose

Antimicrobial

Use

• 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), Coconut Acid, Oleic Acid, Sodium Sulfate, Ethanolamine, Cocamide MEA, Coco-Betaine, Propylene Glycol, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Hydroxypropyl Methylcellulose, Fragrance (Parfum)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRIPLE S GENTLE ANTIBACTERIAL CLEANSER

chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59110-052
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)
Coconut Acid (UNII: 40U37V505D)
Oleic Acid (UNII: 2UMI9U37CP)
Sodium Sulfate (UNII: 0YPR65R21J)
MONOETHANOLAMINE (UNII: 5KV86114PT)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Coco-Betaine (UNII: 03DH2IZ3FY)
Propylene Glycol (UNII: 6DC9Q167V3)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN OIL (UNII: 8470G57WFM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59110-052-34	1000 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2008	12/31/2023
2	NDC:59110-052-67	2000 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/01/2008	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/01/2008	12/31/2023

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

Revised: 12/2020

Document Id: 9e6fe284-1f87-45d1-81da-acb84ef7aacf

Set id: e5992562-633d-4ffc-ae0a-c89385768d02

Version: 2

Effective Time: 20201222