Royal Antibacterial Foam Hand Wash

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 Guangzhou Gotdya Fine Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROYAL ANTIBACTERIAL FOAM HAND WASH- chloroxylenol solution 
Guangzhou Gotdya Fine Chemical Co., Ltd.

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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Royal Antibacterial Foam Hand Wash

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.

ROYAL ANTIBACTERIAL FOAM HAND WASH 
chloroxylenol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76591-107
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: 76591-107-01	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 - Guangzhou Gotdya Fine Chemical Co., Ltd. (551470189)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Gotdya Fine Chemical Co., Ltd.		551470189	manufacture(76591-107)

Revised: 3/2021

Document Id: 7c6c3bb5-8b7a-48cb-8cd6-aa88df259f38

34390-5

Set id: 2e548ffa-a25c-4200-9c3d-aaf6b342f963

Version: 1

Effective Time: 20210308