ANTIBACTERIAL HAND SHEA BUTTER SCENTED- chloroxylenol liquid 
PANROSA ENTERPRISES, INC.

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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Antibacterial Hand Soap Shea Butter Scented

Drug Facts

Active ingredient

Chloroxylenol 0.25%

Purpose

Antibacterial

Uses

Warnings

For external use only

When using this product

  • Avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if

  • irritation and redness develops.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

Inactive Ingredients:

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide MEA, Glycerin, Glycol Stearate, Sodium Chloride, Peg-150 Distearate, Citric Acid, Fragrance, Methylisothiazolinone Methylchloroisothiazolinone, Disodium EDTA

Package Labeling:

shea_soap

ANTIBACTERIAL HAND SHEA BUTTER SCENTED 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-520
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50302-520-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/20/2016
Labeler - PANROSA ENTERPRISES, INC. (859957578)

Revised: 10/2021
Document Id: cece7e0d-0ac6-2c0f-e053-2995a90a37cf
Set id: 61b13236-9669-4f0f-9577-0d1df4e93fb5
Version: 6
Effective Time: 20211020
 
PANROSA ENTERPRISES, INC.