Drug Details [pdf]

FRESHSCENT SPORT ANTIBACTERIAL- triclocarban soap
New World Imports, 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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OTC Active Ingredient

Triclocarban 0.60%

Antibacterial

Keep out of Reach of Children

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

Uses

For washing to decrease bacteria on the skin

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 or redness develops.

Directions

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

Inactive Ingredients

Coconut Oil, Edetic Acid, Palm Nut Oil, Palm Oil, Titanium Dioxide, Water, Fragrance, FD and C Blue No 1, D and C Red No 33

Label

FRESHSCENT SPORT ANTIBACTERIAL
triclocarban soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-044
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)	TRICLOCARBAN	6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)
EDETIC ACID (UNII: 9G34HU7RV0)
PALM KERNEL OIL (UNII: B0S90M0233)
Palm Oil (UNII: 5QUO05548Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
water (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	blue (Blue)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 51824-044-05	142 g in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2014	06/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/01/2014	06/01/2019

Labeler - New World Imports, Inc (075372276)

Revised: 8/2017

Document Id: 21c58a20-20f2-49a4-bb5d-e197491e6e44

Set id: 8ecbd91e-a354-4b98-abee-43b7e6d6414a

Version: 5

Effective Time: 20170808