TRICLOSAN FREE ANTIBACTERIAL 7.5 OZ (OCEAN) ANTIBACTERIAL- chloroxylenol liquid

Triclosan Free Antibacterial 7.5 oz (Ocean) by

Drug Labeling and Warnings

Triclosan Free Antibacterial 7.5 oz (Ocean) by is a Otc medication manufactured, distributed, or labeled by Rejoice International Corp., China Ningbo Shangge Cosmetic Technology Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Purpose

Antibacterial

ACTIVE INGREDIENT

Active Ingredient

Chloroexylenol, 0.3%

INDICATIONS & USAGE

USAGE

For hand washing to decrease bacteria on the skin

DOSAGE & ADMINISTRATION

Directions

Pump into hands

Lather vigorously for at least 15 seconds

Rinse and dry thoroughly

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.

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 doctor if irritation and redness develops

INACTIVE INGREDIENT

WATER, SODIUM LAURETH SULFATE, COCAMIDE MEA, SODIUM C14-16 OLEFIN SULFONATE, SODIUM CHLORIDE, PEG-150 DISTEARATE, FRAGRANCE, CITRIC ACID, GLYCERIN, PEG-40 HYDROGENATED CASTOR OIL, DISODIUM EDTA, TOCOPHERYL ACETATE, METHYLCHLOROTHIAZOLINONE, METHYLISOTHIAZOLINONE, FD&C YELLOW NO.5, D&C RED NO. 33; FD&C BLUE NO. 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRICLOSAN FREE ANTIBACTERIAL 7.5 OZ (OCEAN)  ANTIBACTERIAL
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-088
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-088-01	221 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/06/2017

Labeler - Rejoice International Corp. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture(57337-088)