SKINTEGRITY ANTIBACTERIAL HAND FOAMING- triclosan soap
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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978 Skintegrity Foaming Antibacterial Hand Soap

Active ingredient

Triclosan 0.5%

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

apply a small amount, covering hands with product for 30 seconds.
add water, lather and rinse.

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Glycerin, Polyquaternium-7, Cocamide DEA, Disodium Cocamido MIPA-Sulfosuccinate, DMDM Hydantoin, Fragrance, Tetrasodium EDTA, Polyquaternium-10, Aloe Barbadensis Leaf, Tocopheryl Acetate, Citric Acid, Red 33, Yellow 5.

Package/Label Principal Display Panel

Skintegrity Foaming Antibacterial hand soap label

MEDLINE

NDC 53329-978-82

skintegrity

antibacterial hand soap

1.7 fl oz (50 mL)

SKINTEGRITY ANTIBACTERIAL HAND FOAMING
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-978
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCERIN (UNII: PDC6A3C0OX)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE SODIUM (UNII: MP1J8420LU)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-978-84	1000 mL in 1 BAG; Type 0: Not a Combination Product	04/08/2011	03/01/2018
2	NDC:53329-978-82	50 mL in 1 BOTTLE; 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(53329-978)

Revised: 12/2019

Document Id: 9ab127d4-a1f3-93ee-e053-2995a90a5ca8

Set id: 8c01bcd8-6beb-4940-b5b3-02c3dec43cc1

Version: 2

Effective Time: 20191227

Medline Industries, Inc.