AMERIDERM ANTIBACTERIAL WASH- chloroxylenol liquid 
SHIELD LINE LLC

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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AMERIDERM ANTIBACTERIAL FOAM WASH CHLOROXYLENOL

DRUG FACTS

Chloroxylenol, 0.5%

Antibacterial

USES

  • for handwashing to reduce bacteria on skin

WARNINGS

FOR EXTERNAL USE ONLY

When using this product

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

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

DIRECTIONS

  • apply foaming cleanser to dry hands
  • rub hands to spread lather
  • wash for 15-20 seconds
  • rinse and dry hands thoroughly

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

PACKAGE LABELING:

PACKAGE LABEL

AMERIDERM ANTIBACTERIAL WASH 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-8072
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52410-8072-31000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/25/201606/07/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/25/201606/07/2018
Labeler - SHIELD LINE LLC (078518916)

Revised: 6/2018
 
SHIELD LINE LLC