University Medical Pharmaceuticals Antibacterial Hand Soap

University Medical Pharmaceuticals Antibacterial Hand Wash by

Drug Labeling and Warnings

University Medical Pharmaceuticals Antibacterial Hand Wash by is a Otc medication manufactured, distributed, or labeled by University Medical Pharmaceuticals Corp., Enviro Tech Chemical Services Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UNIVERSITY MEDICAL PHARMACEUTICALS ANTIBACTERIAL HAND WASH- chloroxylenol soap 
University Medical Pharmaceuticals Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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University Medical Pharmaceuticals Antibacterial Hand Soap

Drug Facts

Active ingredient

Chloroxylenol 0.3%

Purpose

Antibacterial hand soap

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 & 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 immediately.

Inactive ingredients Water, Alpha Olefin Sulfonate, Oleic sulfonic Acid, Sodium Lauryl Sulfate, Cocoamidopropyl Betaine, Citric Acid, Fragrance, CI 42090 (Blue 1), CI 16035 (Red 40).

KILLS 99.9% OF BACTERIA

NEW

FRESH CLEAN SCENT

Questions?

Call toll free 855-299-8800

Distributed by

UNIVERSITY MEDICAL PHARMACEUTICALS CORP

universitymedical.com | 9671 Irvine Center Drive, Irvine, CA 92618

©2020 All rights reserved. Made in USA with foreign package components.

Packaging

UNIVERSITY MEDICAL PHARMACEUTICALS ANTIBACTERIAL HAND WASH 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50544-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C12-14 OLEFIN SULFONATE (UNII: 7I962MCQ71)
SULFONATED OLEIC ACID (UNII: DDS68Y21OL)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50544-501-11	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/03/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/03/2020	12/31/2021

Labeler - University Medical Pharmaceuticals Corp. (809706252)

Establishment
Name	Address	ID/FEI	Business Operations
Enviro Tech Chemical Services Inc.		805860483	manufacture(50544-501)

Revised: 8/2021

Document Id: cadf0039-d3c1-3736-e053-2a95a90a139c

34390-5

Set id: 5ace7137-171c-48f8-9175-4804a0c702d1

Version: 3

Effective Time: 20210831