Skintegrity by Medline Industries, Inc. Drug Facts

Skintegrity by

Drug Labeling and Warnings

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

Drug Details [pdf]

SKINTEGRITY- 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

Water, PEG-10 Dimethicone, Glycerin, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

foaming hand sanitizer

fragrance free

SKINTEGRITY 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-974
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
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-974-84	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/08/2016	10/23/2018
2	NDC: 53329-974-82	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/22/2016	10/23/2018
3	NDC: 53329-974-80	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/04/2016	10/23/2018
4	NDC: 53329-974-81	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/04/2016	10/23/2018
5	NDC: 53329-974-83	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/07/2016	10/23/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/04/2016	10/23/2018

Labeler - Medline Industries, Inc. (025460908)

Revised: 11/2019

Document Id: 982d0022-91bf-6fea-e053-2995a90a54aa

34390-5

Set id: 32837937-0d9b-09a9-e054-00144ff88e88

Version: 2

Effective Time: 20191125

 

Medline Industries, Inc.