SPASOAP LIQUID ANTIBACTERIAL 2X ULTRA- triclosan solution 
Brands International

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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SpaSoap Liquid Antibacterial 2X Ultra

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 ifirritation or redness develops.

When using this productdo 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 2X Ultra
Refill
64 oz / 1.9L
Hand Soap

Label

SPASOAP LIQUID ANTIBACTERIAL 2X ULTRA 
triclosan solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-102
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:50157-102-641900 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)10/01/201501/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/01/201501/01/2017
Labeler - Brands International (243748238)
Registrant - Sante Manufactruing Inc (252365486)
Establishment
NameAddressID/FEIBusiness Operations
Brands International243748238manufacture(50157-102)

Revised: 10/2023
Document Id: 08a116ac-3cc7-cad6-e063-6294a90a5097
Set id: 8e9a9d97-da06-4fab-b7b9-6245980d35fe
Version: 6
Effective Time: 20231026
 
Brands International