ANTIBACTERIAL AMBER FLORAL- antibacterial amber floral hand soap liquid 
Theochem Laboratories 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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Antibacterial Amber Floral Hand Soap

Active Ingredient:

Triclosan 0.2%

Purpose:

Antimicrobial

Uses:

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

Recommended for repeated use.

Warnings:
For external use only.

When using this product, do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

For Use with Dispenser: Pour contents into the dispenser reservoir. For first use applications, pump dispenser a few times to prime.

For Use as Hand Soap: Wet hands and dispense a small amount of the product into palm. Rub hands to produce lather. Rinse thoroughly with water, then dry hands completely.

For Use as Bath and Body Wash: Apply sparingly. Avoid contact with eyes. Lather and rinse.

Other Information:

Store at room temperature. Avoid extremes of both hot and cold. 

Incative Ingredients:

Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Lauric Diethanolamide, Propylene Glycol, Citric Acid,Tetrasodium salt of EDTA, FD&C Red No 40, FD&C Yellow #6, Fragrance; 1, 2-benzisothiazolin-3-one and 2-methyl-4-isothiazolin-3-one.

PRINCIPAL DISPLAY PANEL

Antibacterial Amber Floral Hand Soap
Luxurious Wash For The Skin
Net Contents: One Gallon (3.785 Liters)

Front panel

Drug Facts

ANTIBACTERIAL AMBER FLORAL 
antibacterial amber floral hand soap liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68878-115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN2 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68878-115-113.785 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/06/200404/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/06/200404/26/2017
Labeler - Theochem Laboratories Inc (004100038)
Establishment
NameAddressID/FEIBusiness Operations
Theochem Laboratories Inc004100038manufacture(68878-115)

Revised: 8/2017
 
Theochem Laboratories Inc