SKINTEGRITY ANTIBACTERIAL HAND BLUE- triclosan soap

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]

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, Tetrasodium EDTA, Glutamic Acid, Leucine, Serine, Phenylalanine, Proline, Glycine, Valine, Isoleucine, Arginine, Citric Acid, Blue 1.

Package/Label Principal Display Panel

Skintegrity Antibacterial Hand Soap bag label

NDC: 53329-043-20

skintegrity

antibacterial hand soap

27 fl oz (800 mL)

Package Box Label - Back and Side

Skintegrity Antibacterial Hand Soap box, back and side

Package Box Label - Front and side

Skintegrity Antibacterial Hand Soap box, front and side

INGREDIENTS AND APPEARANCE

SKINTEGRITY ANTIBACTERIAL HAND  BLUE
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.5 mL  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)
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-043-20	1 in 1 BOX
1		800 mL in 1 BAG

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

Labeler - Medline Industries, Inc. (025460908)