NEXT 1 ANTI-BACTERIAL- triclocarban soap
Keefe Group

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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NEXT 1 Anti-bacterial Bar Soap

Active ingredient

Triclocarban 1.5%

Purpose

Antibacterial

Uses

For washing to decrease bacteria on the skin

Warnings

For external use only

When using this product

In case of eye contact, flush with water

Stop use and ask a doctor if

Irritation and redness develops

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Wet bar with water
Lather vigorously and wash skin
Rinse and dry thoroughly

Inactive Ingredients

Sodium Palmate, Sodium Palm Kernelate, Water, Calcium Carbonate, Zea Mays (Corn) Starch, Glycerin, Sodium Chloride, Sodium Lauryl Sulfate, Fragrance, Titanium Dioxide, Coconut Acid, Citric Acid, Etidronic Acid, Tetrasodium EDTA

May contain Caramel.

Distributed by: Courtesy Products.

Los Angeles, CA 92335.

MADE IN COLOMBIA

NEXT 1 Anti-bacterial Bar Soap 5oz/142g (51870-000-05)

NEXT 1 ANTI-BACTERIAL
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51870-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)	TRICLOCARBAN	1.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
WATER (UNII: 059QF0KO0R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
GLYCERIN (UNII: PDC6A3C0OX)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCONUT ACID (UNII: 40U37V505D)
ETIDRONIC ACID (UNII: M2F465ROXU)
EDETATE SODIUM (UNII: MP1J8420LU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51870-000-05	142 g in 1 PACKAGE; Type 0: Not a Combination Product	10/31/2013	09/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/31/2013	09/01/2017

Labeler - Keefe Group (839439601)

Name	Address	ID/FEI	Business Operations
Establishment
HADA International S.A		882405152	manufacture(51870-000)

Revised: 1/2018

Document Id: 63620932-784f-5436-e053-2991aa0a6d1c

Set id: 38baa969-11e7-4d8c-ba7d-63e19ad362f3

Version: 4

Effective Time: 20180122

Keefe Group