HAND ESSENTIALS ANTIBACTERIAL- triclosan soap

Hand Essentials Antibacterial by

Drug Labeling and Warnings

Hand Essentials Antibacterial by is a Otc medication manufactured, distributed, or labeled by HU-FRIEDY MFG. CO., 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 skin

Warnings

For external use only.

When using this product

• avoid contact with eyes. In case of eye contact, 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., Yellow 5, Red 33

Package/Label Principal Display Panel

Hu-Friedy

HAND ESSENTIALS

Antibacterial Soap

Effective against bacteria, yet gentle enough for frequent use.

Part-code: IMS-1506

MADE IN USA

Hu-Friedy

16 Fl oz (473 mL)

INGREDIENTS AND APPEARANCE

HAND ESSENTIALS ANTIBACTERIAL 
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65626-017
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
POLYQUATERNIUM-7 (76/24 ACRYLAMIDE/DADMAC; 120000 MW) (UNII: AAJ238UT03)
GLYCERIN (UNII: PDC6A3C0OX)
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 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: 65626-017-06	473 mL in 1 BOTTLE, PUMP
2	NDC: 65626-017-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/01/2010

Labeler - HU-FRIEDY MFG. CO., INC. (005085972)