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NDC 66294-0050-27 PRIME SOURCE Antibacterial Hand So ap 0.003 mg/mL Details

PRIME SOURCE Antibacterial Hand So ap 0.003 mg/mL

PRIME SOURCE Antibacterial Hand So ap is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by BUNZL. The primary component is CHLOROXYLENOL.

Product Information

NDC	66294-0050
Product ID	66294-050_d9d36adf-3977-4a95-bbc0-04c065491a14
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	PRIME SOURCE Antibacterial Hand So ap
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	BUNZL
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 66294-0050-27 (66294005027)

Pricing Information	N/A
NDC Package Code	66294-050-27
Billing NDC	66294005027
Package	800 mL in 1 PACKAGE (66294-050-27)
Marketing Start Date	2008-10-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 819c5e11-2d81-4197-bd02-c93588010f2d 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

PRIME SOURCE ANTIBACTERIAL HAND SO AP

chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66294-050
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:66294-050-27	800 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/15/2008	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/15/2008	12/31/2023

Labeler - BUNZL (799540588)

Revised: 12/2020

Document Id: d9d36adf-3977-4a95-bbc0-04c065491a14

Set id: 819c5e11-2d81-4197-bd02-c93588010f2d

Version: 2

Effective Time: 20201222