SpaSoap Liquid Antibacterial

SpaSoap Liquid Antibacterial

Drug Labeling and Warnings

Drug Details

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SPASOAP LIQUID ANTIBACTERIAL - triclosan solution 
Brands International

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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SpaSoap Liquid Antibacterial

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 and ask a doctor if irritation or redness develops.

When using this product do not get 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 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
64 oz / 1.9L
Hand Soap

Label

SPASOAP LIQUID ANTIBACTERIAL  
triclosan solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50157-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50157-101-641900 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/24/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/24/2015
Labeler - Brands International (243748238)
Registrant - Sante Manufacturing Inc (252365486)
Establishment
NameAddressID/FEIBusiness Operations
Brands International243748238manufacture(50157-101)

Revised: 5/2016
 
Brands International


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