SKINTEGRITY FOAMING HAND SANITIZER ALCOHOL FREE- benzethonium chloride solution
Medline Industries, Inc.

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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976 Skintegrity Foaming Hand Soap

Active ingredient

Benzethonium Chloride 0.2%

Purpose

Antiseptic Handwash

Uses

for handwashing to decrease bacteria on the skin

Warnings

For external use only.

When using this product

avoid contact with eyes. In case of eye contact, immediately flush with water.

Stop use and ask a doctor if

irritation or redness develop
condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place a pumpful of product in one hand
wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

Water, Propylene Glycol, Phenoxyethanol,Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Fragrance, Tetrasodium EDTA, Aloe Barbadensis Leaf, Tocopheryl Acetate.

Package Label

NDC 53329-976-84

Skintegrity

alcohol free foaming hand sanitizer

33.8 fl oz (1000 mL)

SKINTEGRITY FOAMING HAND SANITIZER ALCOHOL FREE
benzethonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-976
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYETHYLENE GLYCOL 350 (UNII: ZBR3T82M2V)
GLYCERYL COCOATE (UNII: WVK1CT5994)
EDETATE SODIUM (UNII: MP1J8420LU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-976-84	1000 mL in 1 BAG; Type 0: Not a Combination Product	04/08/2011	03/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/08/2011	03/01/2018

Labeler - Medline Industries, Inc. (025460908)

Name	Address	ID/FEI	Business Operations
Establishment
KUTOL PRODUCTS COMPANY		004236139	manufacture(53329-976)

Revised: 12/2019

Document Id: 9ab120be-ad12-563f-e053-2a95a90a43af

Set id: 3637818b-8eca-4a32-ac15-f116c1aaae52

Version: 2

Effective Time: 20191227

Medline Industries, Inc.