Skintegrity Foaming Hand Sanitizer by Medline Industries, Inc. Drug Facts

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 FRAGRANCE FREE- ethyl alcohol 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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Drug Facts

Active ingredient

Ethyl Alcohol 62% v/v

Purpose

Antiseptic Handwash

Uses

• for handwashing to decrease bacteria on the skin

Warnings

For external use only.

Flammable, keep away from heat or flames.

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 hands. Wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

DEA-C8-18 perfluoroalkylethyl phosphate, glycerin, water.

Package Label

NDC: 53329-975-82

Skintegrity

foaming hand sanitizer

fragrance free

1.7 fl oz (50 mL)

SKINTEGRITY FOAMING HAND SANITIZER  FRAGRANCE FREE
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-975
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-975-84	1000 mL in 1 BAG; Type 0: Not a Combination Product	04/08/2011	12/31/2019
2	NDC: 53329-975-82	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2011	12/31/2019
3	NDC: 53329-975-80	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2011	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/08/2011	12/31/2019

Labeler - Medline Industries, Inc. (025460908)

Revised: 5/2016

Document Id: 32a77f4c-85a6-7497-e054-00144ff8d46c

Set id: bc577dbf-c82b-432a-8dbc-c30957230cb8

Version: 3

Effective Time: 20160512

 

Medline Industries, Inc.