AMERIDERM ANTIBACTERIAL WASH- parachlorometaxylenol 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 Foaming - ALL-211

Drug Facts

Active Ingredient

Parachlorometaxylenol 0.3% w/w

Purpose

Antiseptic

Uses

Warnings

Keep out of reach of children

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

Directions

Inactive Ingredients

Citric Acid Monohydrate, Cocamidopropyl Betaine, Coco Diethanolamide, Disodium Laureth Sulfosuccinate, Edetate Disodium Anhydrous, Ethylhexyl Glycerin, Fragrance, Glyceryl oleate, PEG-7 Glyceryl Cocoate, Phenoxyethanol, Sodium Laureth 3 Sulfate, Sulisobenzone, Water

Package Label

DRUG FACT PANEL

AMERIDERM ANTIBACTERIAL WASH 
parachlorometaxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-8073
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.003 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SULISOBENZONE (UNII: 1W6L629B4K)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52410-8073-21000 mL in 1 POUCH; Type 0: Not a Combination Product06/12/2018
2NDC:52410-8073-43780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/12/2018
Labeler - SHIELD LINE LLC (078518916)

Revised: 1/2022
Document Id: d57aad30-732d-2203-e053-2a95a90aeb0c
Set id: 6e652a7d-76bb-bb2d-e053-2a91aa0aac50
Version: 4
Effective Time: 20220113
 
SHIELD LINE LLC