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.

----------

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 Product_Labels_Antibacterial Foam Hand Wash

ROYAL ANTIBACTERIAL FOAM HAND WASH 
chloroxylenol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76591-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76591-107-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/04/2016
Labeler - Guangzhou Gotdya Fine Chemical Co., Ltd. (551470189)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Gotdya Fine Chemical Co., Ltd.551470189manufacture(76591-107)

Revised: 3/2021
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.