ROYAL ANTIBACTERIAL FOAM HAND WASH- chloroxylenol solution

Royal Antibacterial Foam Hand Wash by

Drug Labeling and Warnings

Royal Antibacterial Foam Hand Wash by is a Otc medication manufactured, distributed, or labeled by CWGC LA Inc., Guangzhou Gotdya Fine Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chloroxylenol, 0.5%

Purpose

Antibacterial

Uses

• For handwashing to reduce bacteria on the skin

Warnings

For external use only

When using this product

• Avoid contact with eyes. In case of eye contact, flush with water

Keep out of reach of children.

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

Directions

• Apply foaming cleanser to dry hands
• Rub hands together to spread lather
• Wash for 15-20 seconds
• Rinse & dry hands thoroughly

Inactive ingredients

Water, Sodium Laureth Sulfate, Isopropyl Alcohol, Cocamidopropyl Betaine, Decyl Glucoside, SODIUM C14-16 OLEFIN SULFONATE, Hydrogenated castor Oil, DMDM Hydantoin, Citric Acid, Fragrance, FD&C Blue No.1, FD&C Yellow No.5.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYAL ANTIBACTERIAL FOAM HAND WASH 
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70415-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70415-201-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/04/2016

Labeler - CWGC LA Inc. (034967904)