018 Skintegrity Antibacterial Hand Soap (amber)

Skintegrity Antibacterial Hand by

Drug Labeling and Warnings

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

Drug Details [pdf]

SKINTEGRITY ANTIBACTERIAL HAND AMBER- 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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018 Skintegrity Antibacterial Hand Soap (amber)

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

• pump into wet hands
• lather vigorously for at least 15 seconds
• rinse and dry thoroughly

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Disodium Cocamido MIPA-Sulfosuccinate, Glycerin, Polyquaternium-7, DMDM Hydantoin, BHT, Fragrance, Citric Acid, Tetrasodium EDTA, Glutamic Acid, Leucine, Serine, Phenylalanine, Proline, Glycine, Valine, Isoleucine, Arginine, Citric Acid, Yellow 5, Red 33.

Package/Label Principal Display Panel

MEDLINE

NDC: 53329-018-04

skintegrity

antibacterial hand soap

4 fl oz (118 mL)

SKINTEGRITY ANTIBACTERIAL HAND  AMBER
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-018
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLYCERIN (UNII: PDC6A3C0OX)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
DMDM HYDANTOIN (UNII: BYR0546TOW)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
GLUTAMIC ACID (UNII: 3KX376GY7L)
LEUCINE (UNII: GMW67QNF9C)
SERINE (UNII: 452VLY9402)
PHENYLALANINE (UNII: 47E5O17Y3R)
PROLINE (UNII: 9DLQ4CIU6V)
GLYCINE (UNII: TE7660XO1C)
VALINE (UNII: HG18B9YRS7)
ISOLEUCINE (UNII: 04Y7590D77)
ARGININE (UNII: 94ZLA3W45F)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-018-20	1 in 1 BOX	04/08/2011	03/01/2018
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 53329-018-84	1 in 1 BOX	04/08/2011	03/01/2018
2		1000 mL in 1 BAG; Type 0: Not a Combination Product
3	NDC: 53329-018-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2011	03/01/2018
4	NDC: 53329-018-08	221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2011	03/01/2018
5	NDC: 53329-018-06	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2011	03/01/2018
6	NDC: 53329-018-25	3785 mL in 1 JUG; Type 0: Not a Combination Product	04/08/2011	03/01/2018

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

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
KUTOL PRODUCTS COMPANY		004236139	manufacture(53329-018)

Revised: 12/2019

Document Id: 9ab0dbff-3fcf-333f-e053-2a95a90a2c9b

34390-5

Set id: 747ab277-7215-424d-907b-9b38a7f33160

Version: 3

Effective Time: 20191227

 

Medline Industries, Inc.