HIGH FIVE ANTIBACTERIAL HAND- chloroxylenol soap 
Janisource, LLC

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Active Ingredient

Chloroxylenol

Purpose

Antiseptic

Uses

• Handwash to help decrease bacteria on the skin.

Warnings

For external use only.
Do not use in the eyes. In case of contact, immediately flush eyes with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.
• Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Laureth-3 Sulfate, Sodium Chloride, Propylene glycol, Propanediol, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5, and Red 40.

Principal Display Panel

HIGH FIVE ANTIBACTERIAL HAND 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49557-701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL1 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
PROPANEDIOL (UNII: 5965N8W85T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EUGENOL (UNII: 3T8H1794QW)  
CINNAMALDEHYDE (UNII: SR60A3XG0F)  
WATER (UNII: 059QF0KO0R)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Colororange (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49557-701-413.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)03/08/2023
Labeler - Janisource, LLC (079224675)

Revised: 11/2023
Document Id: 09d2bc09-6d90-bcf9-e063-6294a90af0a2
Set id: f665a352-775d-ebcc-e053-2a95a90ae362
Version: 2
Effective Time: 20231110
 
Janisource, LLC