AMERIWASH- 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.

----------

AMERIDERM AMERIWASH PCMX 0.3%

Drug Facts

Active Ingredient

Parachlorometaxylenol 0.3% w/w

Purpose

Antimicrobial

Uses

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

Warnings

FOR EXTERNAL USE ONLY

When using this product

Do not use in or near the eyes
Incase of eye contact rinse the eyes thoroughly with water

Stop use and ask a doctor if

Irritation or rash appears or lasts

Keep out of reach of children

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

Directions

Wet hands
Apply a small amount of product and work into lather
Rinse well and dry hands completely

Inactive Ingredients

Alpha Hexylcinnamaldehyde, Citric Acid Monohydrate, Cocamidopropyl Betaine, Coco Diethanolamide, D&C Red No. 33, DMDM Hydantoin, Edetate Disodium Anhydrous, FD&C Yellow No.5, FD&C Yellow No.6, PEG-7 Glyceryl Cocoate, Sodium Chloride, Sodium, Laureth Sulfate, Sulisobenzone, Water

AMERIWASH DRUG FACT PANEL

Principal Display & Drug Fact Panel

AMERIWASH
parachlorometaxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52410-8038
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SULISOBENZONE (UNII: 1W6L629B4K)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52410-8038-3	800 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2017
2	NDC:52410-8038-4	1000 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2017
3	NDC:52410-8038-5	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/01/2017

Labeler - SHIELD LINE LLC (078518916)