SPA ORIGINALS ANTIBACTERIAL GOLD HAND- triclosan soap

Spa Originals Antibacterial Gold Hand by

Drug Labeling and Warnings

Spa Originals Antibacterial Gold Hand by is a Otc medication manufactured, distributed, or labeled by Custom Solutions, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

Spa Originals

Antibacterial Gold

HAND SOAP

enriched with vitamin e

Kills Germs, Neutralizes Odors

7.5 fl. oz. (221mL)

Package Labeling

INGREDIENTS AND APPEARANCE

SPA ORIGINALS ANTIBACTERIAL GOLD HAND 
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76405-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.12 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76405-011-02	221 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/22/2011

Labeler - Custom Solutions, Inc (966678240)