TRICLOSAN- antibacterial liquid soap refill soap

Triclosan by

Drug Labeling and Warnings

Triclosan by is a Otc medication manufactured, distributed, or labeled by Brands International, Sante Manufacturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Triclosan 0.115%

Purpose

Antibacterial

Uses

for handwashing or decrease bacteria to the skin

WARNINGS

For external use only

Stop use and ask a doctor if

irritation or redness develops

When using this product

• do not get it into eyes, if contact occurs, rinse eye thoroughly with water

Keep out of reach of children

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

Directions

• Wet hands
• apply palmful to hands
• scrub throughly
• rinse

Inactive Ingredients

Water, Sodium Laureth Sulfate, Sodium Chloride, DMDM Hydantoin, Citric Acid, Fragrance, EDTA, Yellow #5, Red# 33

Package Label

​Spa Soap

Antibacterial

Liquid Soap

Refill

INGREDIENTS AND APPEARANCE

TRICLOSAN 
antibacterial liquid soap refill soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1.15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETIC ACID (UNII: 9G34HU7RV0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-119-32	947 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/03/2016

Labeler - Brands International (243748238)

Registrant - Sante Manufacturing Inc (252365486)

Establishment
Name	Address	ID/FEI	Business Operations
Brands International		243748238	manufacture(50157-119)