NEXT 1 ANTI-BACTERIAL SPORT- triclocarban soap
HADA International S.A

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 Bar

Active ingredient

Triclocarban 1.5%

Purpose

Antibacterial

Uses

For washing to decrease bacteria n 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, Menthol Coconut Acid, Citric Acid, Iron Oxide, Etidronic Acid, Tetrasodium EDTA, Titanium Dioxide, Avena Sativa Kernel Extract,Mentha Piperita Leaf Extract,Chamomilla Recutita Flower Extract, Aloe Barbadensis Leaf Extract,Camelia Sinensis Leaf Extract,Taurine. May contain Caramel.

Distributed by: Courtesy Products.

Los Angeles, CA 92335. MADE IN

COLOMBIA

NSOC -13CO

• Kills germs

Elimina los gérmenes

• Odor protection

Protección contra malos olores

Label

label

NEXT 1 ANTI-BACTERIAL SPORT
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42377-001
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 PALMATE (UNII: S0A6004K3Z)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
WATER (UNII: 059QF0KO0R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
GLYCERIN (UNII: PDC6A3C0OX)
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)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42377-001-05	142 g in 1 BOX; Type 0: Not a Combination Product	06/06/2013	09/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/06/2013	09/01/2017

Labeler - HADA International S.A (882405152)

Name	Address	ID/FEI	Business Operations
Establishment
HADA International S.A		882405152	manufacture(42377-001)

Revised: 1/2018

Document Id: 63622515-a454-0adc-e053-2a91aa0a3d26

Set id: 2281871d-1210-4f7a-aff8-0ee19311f669

Version: 2

Effective Time: 20180122

HADA International S.A