Waxie Clear Tone Antibacterial by Waxie's Enterprises, LLC / Midlab, Inc.

Waxie Clear Tone Antibacterial by

Drug Labeling and Warnings

Waxie Clear Tone Antibacterial by is a Otc medication manufactured, distributed, or labeled by Waxie's Enterprises, LLC, Midlab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WAXIE CLEAR TONE ANTIBACTERIAL- pcmx soap 
Waxie's Enterprises, 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.

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Active Ingredient

PCMX 0.1%

Purpose

Antiseptic Handwashing

Uses

 Handwash to help decrease bacteria on the skin.

Warning:

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

Stop use and ask 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

WAXIE CLEAR TONE ANTIBACTERIAL 
pcmx soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61666-701
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 CHLORIDE (UNII: 451W47IQ8X)  
PROPANEDIOL (UNII: 5965N8W85T)  
CINNAMALDEHYDE (UNII: SR60A3XG0F)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EUGENOL (UNII: 3T8H1794QW)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colororange (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61666-701-413.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/12/202103/27/2023
Labeler - Waxie's Enterprises, LLC (029142577)
Registrant - Midlab, Inc. (047371463)
Establishment
NameAddressID/FEIBusiness Operations
Midlab, Inc.047371463manufacture(61666-701)

Revised: 3/2023