AMERIDERM ANTIBACTERIAL WASH- parachlorometaxylenol liquid

AmeriDerm Antibacterial Wash by

Drug Labeling and Warnings

AmeriDerm Antibacterial Wash by is a Otc medication manufactured, distributed, or labeled by SHIELD LINE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredient

Parachlorometaxylenol 0.3% w/w

Purpose

Antiseptic

Uses

• Handwash to help reduce bacteria on the skin that potentially can cause disease
• Recommended for repeat use

Warnings

• For external use only
• Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water
• Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours

Keep out of reach of children

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

Directions

• Wet hands with water and dispense sufficient amount of product into cupped palm of hand
• Wash both hands thoroughly for 15 seconds
• Rince under running water and dry thoroughly

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

INGREDIENTS AND APPEARANCE

AMERIDERM ANTIBACTERIAL WASH 
parachlorometaxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52410-8073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.003 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
GLYCERYL OLEATE (UNII: 4PC054V79P)
SULISOBENZONE (UNII: 1W6L629B4K)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52410-8073-2	1000 mL in 1 POUCH; Type 0: Not a Combination Product	06/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/12/2018

Labeler - SHIELD LINE LLC (078518916)