SPASOAP LIQUID ANTIBACTERIAL- triclosan solution

SpaSoap Liquid Antibacterial by

Drug Labeling and Warnings

SpaSoap Liquid Antibacterial 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 to decrease bacteria on the skin

Warnings

For external use only.

STOP USE

Stop use and ask a doctor if irritation or redness develops.

WHEN USING

When using this product do not get into eyes. If contact occurs, rinse eye thoroughly with water.

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.

Directions

• wet hands
• apply palmful to hands
• scrub thoroughly
• rinse
  

Inactive ingredients

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

Package Label

SpaSoap

Liquid Soap
Antibacterial
Refill
16 oz / 500ml
Hand Soap

INGREDIENTS AND APPEARANCE

SPASOAP LIQUID ANTIBACTERIAL  
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-111
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
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETIC ACID (UNII: 9G34HU7RV0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-111-16	500 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	10/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2015

Labeler - Brands International (243748238)

Registrant - Sante Manufacturing Inc (252365486)

Establishment
Name	Address	ID/FEI	Business Operations
Brands International		243748238	manufacture(50157-111)