AMERIWASH- parachlorometaxylenol liquid

AMERIWASH by

Drug Labeling and Warnings

AMERIWASH 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

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

INGREDIENTS AND APPEARANCE

AMERIWASH 
parachlorometaxylenol liquid

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2017

Labeler - SHIELD LINE LLC (078518916)