AMERIWASH ANTIBACTERIAL- parachlorometaxylenol liquid

AmeriWash Antibacterial by

Drug Labeling and Warnings

AmeriWash Antibacterial by is a Otc medication manufactured, distributed, or labeled by Inopak, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Parachlorometaxylenol

Purpose

Antiseptic

Uses

Handwash to help reduce bacteria on the skin that

   potentially can cause disease.

Recommended for repeated use.

Warnings

For external use only.

Keep out of eyes, ears, or mouth. In case of eye 

   contact, flush eyes with water.

Keep out of reach of children. If swallowed, get

   medical help or contact a Poison Control Center

   right away.

When Using

Keep out of eyes, ears, or mouth.

Stop Using

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

Children

Keep out of reach of children. 

Directions

Wet hands with water and dispense sufficient

    amount of product into cupped palm of hand.

Wash both hands thoroughly for 15 seconds.

Rinse under running water and dry thoroughly.

Inactive Ingredients

Citric Acid, Cocamide DEA, D&C Red 4, DMDM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, Water

AmeriWash Single Label

• 5031-AMD Rev# 1.0 AmeriWash™ Antimicrobial Lotion Hand Soap with PCMX Reorder No: 205 1000 ml (33.8 fl. Oz.) AMD-80384 Manufactured for: Shield Line LLC, Hackensack, NJ 07601, USA www.ameriderm.com:

  Drug Facts

  Active Ingredient Purpose

  Parachlorometaxylenol 0.3% w/w……. Antiseptic

  Uses

  Handwash to help reduce bacteria on the skin that

  potentially can cause disease.

  Recommended for repeated use.

  Warnings

  For external use only.

  Keep out of eyes, ears, or mouth. In case of eye

  contact, flush eyes with water.

  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.

  Rinse under running water and dry thoroughly.

  Inactive ingredients Citric Acid, Cocamide DEA, D&C Red 4, DMDM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, Water

AmeriWash Case Label

AmeriDerm
REORDER NO: ALL-205	AMD-80384
AMERIWASH Wt:     1000ml (33.8 FL OZ) Qty:    10 Pouches Per Case	Manufactured for: Shield Line LLC Hackensack, NJ 07601 Made in USA
Label Part#: 5031-AMD-CS
Revision#: 1.0	1 03 52410 80384 7

INGREDIENTS AND APPEARANCE

AMERIWASH ANTIBACTERIAL 
parachlorometaxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58575-405
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALCOHOL (UNII: 3K9958V90M)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58575-405-01	1000 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2018
2	NDC: 58575-405-02	10000 mL in 1 CASE; Type 0: Not a Combination Product	01/01/2018
3	NDC: 58575-405-03	800 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2018

Labeler - Inopak, Ltd. (194718243)

Establishment
Name	Address	ID/FEI	Business Operations
Inopak, Ltd.		194718243	manufacture(58575-405)