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Antibacterial Hand Rose Scented

Dosage form: liquid
Ingredients: CHLOROXYLENOL 2.5mg in 1mL
Labeler: PANROSA ENTERPRISES, INC.
NDC Code: 50302-530

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.

Antibacterial Hand Soap Rose Scented

Drug Facts

Active ingredient

Chloroxylenol 0.25%

Purpose

Antibacterial

Uses
  • for handwashing to decrease bacteria on the skin

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
  • pump into hands, wet as needed
  • lather vigorously for at leat 15 seconds
  • wash skin, rinse and dry thoroughly

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:

ANTIBACTERIAL HAND ROSE SCENTED 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-530
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
COCO MONOETHANOLAMIDE 
GLYCERIN 
GLYCOL STEARATE 
SODIUM CHLORIDE 
PEG-150 DISTEARATE 
CITRIC ACID MONOHYDRATE 
METHYLISOTHIAZOLINONE 
METHYLCHLOROISOTHIAZOLINONE 
EDETATE DISODIUM 
Packaging
#Item CodePackage Description
1NDC:50302-530-00500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/20/2016
Labeler - PANROSA ENTERPRISES, INC. (859957578)
Establishment
NameAddressID/FEIOperations
Reward Daily Chemical (Jiangsu) Co., Ltd.421286476manufacture(50302-530)

 
PANROSA ENTERPRISES, INC.

Medically reviewed on Apr 6, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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