HOLIDAY ELEGANCEFROSTED GINGERBREFROSTED GINGERBRE FROSTED GINGERBREAD- triclosan liquid

Holiday EleganceFrosted GingerbreFrosted Gingerbre by

Drug Labeling and Warnings

Holiday EleganceFrosted GingerbreFrosted Gingerbre by is a Otc medication manufactured, distributed, or labeled by Triz Laboratories Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients: Aloe Barbadensis Leaf

Extract, Benzophenone - 4, Blue 1, Cocomide DEA,

Cocomidopropyl Betaine, Citric Acid, Disodium EDTA,

DMDM Hydantoin, Methylchlorisothiazolinone, Parfum,

Propolene Glycol, Red 33, Retinyl Palmitate, Sodium

Laureth Sulfate, Tocoperyl Acetate, Water (Aqua)

Yellow 5

ACTIVE INGREDIENT

Active Ingredient:

Triclosan 0.3 %

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Use - Handwashing to decrease bacteria

on skin

WARNINGS

Warnings

For external use only.

WHEN USING

When using this product, avoid contact

with eyes. If contact occurs, rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation and

redness develop.

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.

DOSAGE & ADMINISTRATION

Directions - wet hands, work into rich

lather - rinse well

QUESTIONS

Questions?  1 - 800 - FDA - 1088

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOLIDAY ELEGANCEFROSTED GINGERBREFROSTED GINGERBRE  FROSTED GINGERBREAD
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53057-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	.9 g  in 300 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZOPHENONE (UNII: 701M4TTV9O)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53057-003-01	12 in 1 BOX
1		121 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/01/2013

Labeler - Triz Laboratories Ltd. (421290822)