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NDC 66294-0431-40 Prime Source ULTRA Energy Plum Antibacterial Dye Free Foam Hand So ap 0.005 mg/mL Details

Prime Source ULTRA Energy Plum Antibacterial Dye Free Foam Hand So ap 0.005 mg/mL

Prime Source ULTRA Energy Plum Antibacterial Dye Free Foam Hand So ap is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by BUNZL Distribution. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	66294-0431
Product ID	66294-431_64648bfe-4182-438a-a742-18275e075714
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 ULTRA Energy Plum Antibacterial Dye Free Foam Hand So ap
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.005
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	BUNZL Distribution
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 66294-0431-40 (66294043140)

Pricing Information	N/A
NDC Package Code	66294-431-40
Billing NDC	66294043140
Package	1200 mL in 1 PACKAGE (66294-431-40)
Marketing Start Date	2017-11-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1815ca2d-5c6b-48e0-96a5-8a6e291e4fb2 Details

Active ingredient

Benzalkonium Chloride 0.5%

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), Propanediol, Glycerin, Cocamidopropyl Betaine, PEG-80 Sorbitan Laurate, Citric Acid, Ethylhexylglycerin, Lauramine Oxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Fragrance (Parfum), Phenoxyethanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRIME SOURCE ULTRA ENERGY PLUM ANTIBACTERIAL DYE FREE FOAM HAND SO AP

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66294-431
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.005 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
Glycerin (UNII: PDC6A3C0OX)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
PEG-80 Sorbitan Laurate (UNII: 239B50Y732)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Ethylhexylglycerin (UNII: 147D247K3P)
Lauramine Oxide (UNII: 4F6FC4MI8W)
POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66294-431-40	1200 mL in 1 PACKAGE; Type 0: Not a Combination Product	11/30/2017	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/30/2017	12/31/2023

Labeler - BUNZL Distribution (799540588)

Revised: 12/2020

Document Id: 64648bfe-4182-438a-a742-18275e075714

Set id: 1815ca2d-5c6b-48e0-96a5-8a6e291e4fb2

Version: 2

Effective Time: 20201222