MCD FOAMING ANTIBACTERIAL HAND- chloroxylenol liquid 
Kath Khemicals 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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McD Foaming Antibacterial Hand Soap

Drug Facts

Active ingredient

Chloroxylenol 0.5%

Purpose

Antiseptic Handwash

Uses

Warnings

Do not use

In eyes

When using this product

  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develop

Stop use and ask a doctor if

  • Skin irritation or redness occurs for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive ingredients

water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, citric acid, coco-glucoside, glyceryl oleate, fragrance, methylchloroisothiazolinone, CI 19140 (FD&C Yellow No. 5), methylisothiazolinone,, CI 14700 (FD&C Red. No. 4)

Questions?

Call (586) 275-2646

Package Labeling:

Label

MCD FOAMING ANTIBACTERIAL HAND 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63301-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO GLUCOSIDE (UNII: ICS790225B)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63301-001-011250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/21/2016
Labeler - Kath Khemicals LLC (144333051)

Revised: 12/2017
Document Id: 60e0e318-d118-3b22-e053-2a91aa0a1ab4
Set id: c2215737-8e8f-4461-b38e-996c8c038507
Version: 3
Effective Time: 20171221
 
Kath Khemicals LLC