PANROSA ALCOHOL-FREE HAND SANITIZER WITH REFRESHING ALOE DUAL ACTION MOISTURIZERS- benzalkonium chloride gel 
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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PANROSA Alcohol-Free Hand Sanitizer with Refreshing Aloe Dual Action Moisturizers

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.

Do not use

in ears & mouth.

When using this product,

avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if

redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of this product.

Directions

Other information

Inactive ingredinets

WATER, HYDROXYETHYLCELLULOSE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, PEG-40 HYDROGENATED CASTOR OIL, DISODIUM EDTA, FRAGRANCE, ALOE BARBADENSIS JUICE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE.

Package Labeling:50302-12-50

Label

Package Labeling:50302-12-23

Label2

Package Labeling:59ml

Bottle3

Package Labeling: 118ml

Tube

PANROSA ALCOHOL-FREE HAND SANITIZER WITH REFRESHING ALOE DUAL ACTION MOISTURIZERS 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50302-012-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
2NDC:50302-012-23237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
3NDC:50302-012-5959 mL in 1 TUBE; Type 0: Not a Combination Product04/30/2020
4NDC:50302-012-18118 mL in 1 TUBE; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/13/2020
Labeler - Panrosa Enterprises, Inc. (859957578)

Revised: 7/2020
Document Id: a977b412-4df4-2b8d-e053-2a95a90a887c
Set id: 4ca29b1f-085f-40bb-905d-ae95ceead6bc
Version: 2
Effective Time: 20200702
 
Panrosa Enterprises, Inc.