Cleanslate Foam Hand Soap

Cleanslate Antibacterial Foam by

Drug Labeling and Warnings

Cleanslate Antibacterial Foam by is a Otc medication manufactured, distributed, or labeled by Cleanslate Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEANSLATE ANTIBACTERIAL FOAM- chloroxylenol liquid 
Cleanslate Group 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.

----------

Cleanslate Foam Hand Soap

Drug Facts

Active ingredient

Chloroxylenol 0.3% w/w

Purpose

Antiseptic

Uses

  • handwash to decrease bacteria on the skin that potentially can cause disease.
  • recommended for repeated use.

Warnings

For external use only.

When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

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 thoroughly for 15 seconds
  • rinse under running water and dry thoroughly

Inactive ingredients

water, sodium laureth sulfate, cocamide DEA, DMDM hydantoin, ethyl alcohol, phenoxyethanol, isopropyl alcohol, fragrance, citric acid, FD&C red 4

MFD FOR CLEANSLATE GROUP LLC

1420 EAST LINDEN AVE

LINDEN, NJ 07036

cleanslate

ANTIBACTERIAL FOAM HAND SOAP

With 0.3% CHLOROXYLENOL

33.8 fl. oz. (1000mL)

80586-513 revised Nov 2021

CLEANSLATE ANTIBACTERIAL FOAM 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80586-523
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALCOHOL (UNII: 3K9958V90M)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80586-523-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product11/17/202107/26/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/17/202107/26/2024
Labeler - Cleanslate Group LLC (117657934)

Revised: 1/2023
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.