Pasion Instant Hand Sanitizer

Pasion Instant Hand Sanitizer by

Drug Labeling and Warnings

Pasion Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by MING FAI ENTERPRISE INTERNATIONAL CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PASION INSTANT HAND SANITIZER- alcohol 
MING FAI ENTERPRISE INTERNATIONAL CO., LTD

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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Pasion Instant Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Uses

• to help reduce bacteria on the skin.

Warnings

• For external use only.
• Flammable.
• Keep away from fire or flame.

When using this product

• avoid contact with eyes.
• If contact occurs, rinse thoroughly with water.

Stop using and ask a doctor if

• irritation or redness develops and lasts.

Keep out of reach of children

• In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

• Squeeze a significant amount in your palm and rub hands until fully dry.
• Rinse free.

Other information

• Store below 110°F (43°C).

Inactive ingredients

Water(Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aminomethyl propanol.

Package Labeling:Kit

Package Labeling:

PASION INSTANT HAND SANITIZER 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74548-017

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74548-017-01	1 in 1 KIT	06/15/2020	12/31/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	3 BOTTLE	150 mL

Part 1 of 1

PASION INSTANT HAND SANITIZER 
alcohol gel

Product Information
Item Code (Source)	NDC: 74548-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TEA TREE OIL (UNII: VIF565UC2G)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74548-010-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/15/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/15/2020	12/31/2022

Labeler - MING FAI ENTERPRISE INTERNATIONAL CO., LTD (667902568)

Revised: 3/2023

Document Id: f7aa8c0a-c0be-82bc-e053-6394a90af788

34390-5

Set id: 7fada382-33b1-4b15-88e4-20cb6c590bba

Version: 4

Effective Time: 20230324

 

MI