976 Skintegrity Foaming Hand Soap

Skintegrity Foaming Hand Sanitizer by

Drug Labeling and Warnings

Skintegrity Foaming Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Skintegrity Foaming Hand Sanitizer Alcohol Free 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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-976
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-976-841000 mL in 1 BAG; Type 0: Not a Combination Product04/08/201103/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/08/201103/01/2018
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIBusiness Operations
KUTOL PRODUCTS COMPANY004236139manufacture(53329-976)

Revised: 12/2019
Document Id: 9ab120be-ad12-563f-e053-2a95a90a43af
Set id: 3637818b-8eca-4a32-ac15-f116c1aaae52
Version: 2
Effective Time: 20191227