PANROSA ALCOHOL FREE HAND SANITIZER- benzalkonium chloride gel

Panrosa Alcohol Free Hand Sanitizer by

Drug Labeling and Warnings

Panrosa Alcohol Free Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Panrosa Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

• hand sanitizer to help decrease bacteria on the skin. when water, soap & towel are not available. 
• recommended for repeated use.

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

• pump as need into your palms and thoroughly spread on both hands.
• rub into skin until dry.

Other information

• store at 20°C (68°F to 77°F).
• may dscolor fabrics.

Inactive ingredients

Water, Cetrimonium Chloride, Lauramine Oxide, Cocamide Methyl MEA, Sodium Chloride, Propanediol, Parfum (Fragrance), Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone.

Package Labeling: 50302-004-00

Package Labeling: 50302-004-01

INGREDIENTS AND APPEARANCE

PANROSA ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50302-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50302-004-00	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2020
2	NDC: 50302-004-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/09/2020

Labeler - Panrosa Enterprises, Inc. (859957578)

Establishment
Name	Address	ID/FEI	Business Operations
Panrosa Enterprises, Inc.		859957578	manufacture(50302-004)