SPA ORIGINALS ANTIBACTERIAL GOLD HAND - triclosan soap 
Custom Solutions, 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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Spa Originals Antibacterial Gold Hand Soap

Active Ingredient

Triclosan 0.12%

Purpose

Antibacterial

Uses

For hand washing, sanitizing and to decrease bacteria on the skin

Caution

For external use only.

When using this product


avoid contact with the eyes

Discontinue use and seek medical attention if

skin irritant and redness develops

Keep out of reach of children

Children under six years should be supervised by an adult when using this product. If swallowed, get medical help or contact a Poison Control Center right away.

Directions for use

Proper usage: Wet hands with water. Pump small amount into hands. Lather vigorously for 15 seconds. Rinse and dry thoroghly.


Inactive Ingredients

Water, Sodium Alcohol Ether Sulphate, Coconut Diethanolamide, Sodium Dodecyl Sulfate, Dodecyl Dimethyl Betaine, Citric Acid, Sodium Cloride, Disodium EDTA, DMDM Hydantoin, Fragrance, Vitamin E, FDandC Yellow 5, Yellow 6

MADE IN CHINA
Distrubuted by Custom Solutions, Inc.
Lee's Summit, MO 64064
www.customsolutionsinc.com


Spa Originals

Antibacterial Gold

HAND SOAP

enriched with vitamin e

Kills Germs, Neutralizes Odors

7.5 fl. oz. (221mL)

Package Labeling

Spa Originals Antibacterial Gold Handsoap

SPA ORIGINALS ANTIBACTERIAL GOLD HAND 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76405-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.12 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76405-011-02221 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/22/2011
Labeler - Custom Solutions, Inc (966678240)

Revised: 9/2011
Document Id: 9078ddd7-2401-4e8d-8dac-98d1e2b4f279
Set id: dd5eb381-71a7-43e9-9a5d-702b79f9fb36
Version: 3
Effective Time: 20110927
 
Custom Solutions, Inc