PANROSA ALCOHOL FREE HAND SANITIZER ALOE VERA- 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, Aloe Vera

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 ingredients

Water, Cetrimonium Chloride, Lauramine Oxide, Cocamide Methyl MEA, Sodium Chloride, Propanediol, Parfum (Fragrance), Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C blue No. 1, FD&C yellow No. 5. 

Package Labeling:

Label3

PANROSA ALCOHOL FREE HAND SANITIZER ALOE VERA 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-005
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)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PROPANEDIOL (UNII: 5965N8W85T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50302-005-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/09/2020
Labeler - Panrosa Enterprises, Inc. (859957578)
Establishment
NameAddressID/FEIBusiness Operations
Panrosa Enterprises, Inc.859957578manufacture(50302-005)

Revised: 3/2020
Document Id: a035ba11-14e3-7710-e053-2995a90ae3ad
Set id: a035bcc0-4b5c-be04-e053-2a95a90af813
Version: 1
Effective Time: 20200306
 
Panrosa Enterprises, Inc.