AmeriWash Hand Soap 405

AmeriWash Hand Soap 405

Drug Labeling and Warnings

Drug Details

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AMERIWASH ANTIBACTERIAL- parachlorometaxylenol liquid 
Inopak, Ltd.

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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AmeriWash Hand Soap 405

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, DMDM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, TEA-Lauryl 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

Single Bar Code

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, DMDM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Water

AmeriWash Single Label

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

Case Bar code

Revision#: 1.0

1 03 52410 80384 7

AmeriWash Case Label

AMERIWASH ANTIBACTERIAL 
parachlorometaxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58575-405
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58575-405-011000 mL in 1 POUCH; Type 0: Not a Combination Product01/01/2018
2NDC: 58575-405-0210000 mL in 1 CASE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2018
Labeler - Inopak, Ltd. (194718243)
Establishment
NameAddressID/FEIBusiness Operations
Inopak, Ltd.194718243manufacture(58575-405)

Revised: 10/2019
 
Inopak, Ltd.


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