Puresan Antibacterial liquid soap  408

Puresan Antibacterial liquid soap  408

Drug Labeling and Warnings

Drug Details

k">

PURESAN ANTIBACTERIAL LIQUID- 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.

----------

Puresan Antibacterial liquid soap  408

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 use

If swallowed, get medical help or contact a Poison Control Center ight 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 Ingredient

Citric Acid, Cocamide DEA, DMOM Hydantoin, Ethyl Alcohol, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Water.

Puresan antibacterial liquid soap single label

MADE

IN THE USA

Antibacterial

Liquid Soap

With Moisturizers

1000 ml

Refill Bag LIQUID                                                      puresan

Item# s1000                                            cleaning innovations

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

Rev. 1.01

PO Box 170, Sparta NJ 07871

855.500.8080 puresanusa.com

Puresan single label

Puresan Case label

 Puresan                                                                                              puresanusa.com

Cleaning innovations                                                                      (855) 500-8080

ITEM 3 S1000AB-D-C8

PURESAN Antibacterial LOTION soap

1000ml case of 8 refills

QTY 8

1000ml refills per case

AVRO-S1000-CS                Rev: 1.0                                                8  37654 25785  2

Puresan liquid soap case label

PURESAN ANTIBACTERIAL LIQUID 
parachlorometaxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58575-408
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58575-408-011000 mL in 1 BAG; Type 0: Not a Combination Product01/01/2018
2NDC: 58575-408-028000 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(58575-408)

Revised: 10/2019
 
Inopak, Ltd.


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.