HAND CLEANSE FRESH PEACH SCENT- triclosan soap

Hand Cleanse by

Drug Labeling and Warnings

Hand Cleanse by is a Otc medication manufactured, distributed, or labeled by Volume Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                   Purpose

Triclosan 0.2% ................. Antibacterial

PURPOSE

Uses For handwashing to decrease bacteria on the skin.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Bebelle For Kids

Gently cleanses & kills germs

Anti-Bacterial Hand Soap

Jabon de Manos Antibacterial para Ninos

Fresh Peach Scent

DOSAGE & ADMINISTRATION

Directions

• Pump into hands
• Lather vigorously for at least 15 seconds
• rinse and dry thoroughly

WARNINGS

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 dctor if irritation and redness develops.

INACTIVE INGREDIENT

Inactive Ingredients

water, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide MEA, sodium chloride, PEG-150 distearate, glycerin, fragrance, citric acid, disodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, FD&C yellow no.5, D&C red no.33

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND CLEANSE  FRESH PEACH SCENT
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50523-086
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
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: 50523-086-01	221 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/10/2015

Labeler - Volume Distributors, Inc. (002029544)

Establishment
Name	Address	ID/FEI	Business Operations
Volume Distributors, Inc.		002029544	manufacture(50523-086)