Hand Cleanse Water Melon Scent (Triclosan) Soap [China Ningbo Shangge Cosmetic Technology Corp.] -

HAND CLEANSE WATER MELON SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]
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NDC	58503-085-01
Set ID	9b9181fb-d272-426c-99ab-571044964980
Category	HUMAN OTC DRUG LABEL
Packager	China Ningbo Shangge Cosmetic Technology Corp.
Generic Name
Product Class
Product Number
Application Number	PART333E

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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

Water Melon 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, FD&C blue no.1
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND CLEANSE WATER MELON SCENT
triclosan soap

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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58503-085-01	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 - China Ningbo Shangge Cosmetic Technology Corp. (529287434)

Name	Address	ID/FEI	Business Operations
Establishment
Volume Distributors, Inc.		002029544	manufacture(58503-085)

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