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NDC 54057-0400-40 AFFEX Antibacterial Plum Foam Handwash 0.005 mg/mL Details

AFFEX Antibacterial Plum Foam Handwash 0.005 mg/mL

AFFEX Antibacterial Plum Foam Handwash is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Afflink, Inc.. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	54057-0400
Product ID	54057-400_3714ed61-ba5c-4816-ad69-f2fc81886af9
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	AFFEX Antibacterial Plum Foam Handwash
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	Afflink, 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 54057-0400-40 (54057040040)

Pricing Information	N/A
NDC Package Code	54057-400-40
Billing NDC	54057040040
Package	1200 mL in 1 PACKAGE (54057-400-40)
Marketing Start Date	2017-04-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3f51700a-0e8f-4091-ab0d-6751364304a4 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), Propylene Glycol, Glycerin, Cocamidopropyl Betaine, PEG-80 Sorbitan Laurate, Citric Acid, Ethylhexylglycerin, Lauramine Oxide, Polyquaternium-10, Fragrance (Parfum), Phenoxyethanol, Blue 1 (CI 42090), Red 33 (CI 17200)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AFFEX ANTIBACTERIAL PLUM FOAM HANDWASH

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54057-400
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)
Propylene Glycol (UNII: 6DC9Q167V3)
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)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54057-400-40	1200 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/30/2017
2	NDC:54057-400-42	1250 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/30/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/30/2017

Labeler - Afflink, Inc. (023121150)

Revised: 11/2022

Document Id: 3714ed61-ba5c-4816-ad69-f2fc81886af9

Set id: 3f51700a-0e8f-4091-ab0d-6751364304a4

Version: 2

Effective Time: 20221115