HAND CLEANSE CITRUS BLAST SCENT- triclosan soap
Volume Distributors, 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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Active Ingredient Purpose

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

Uses For handwashing to decrease bacteria on the skin.

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

Bebelle For Kids

Gently cleanses & kills germs

Anti-Bacterial Hand Soap

Jabon de Manos Antibacterial para Ninos

Citrus Blast Scent

Directions

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

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 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

image description

HAND CLEANSE CITRUS BLAST SCENT
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50523-084
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50523-084-01	221 g in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Volume Distributors, Inc. (002029544)

Name	Address	ID/FEI	Business Operations
Establishment
Volume Distributors, Inc.		002029544	manufacture(50523-084)