Pasion Alcohol Wet Wipes by MING FAI ENTERPRISE INTERNATIONAL CO., LTD Pasion Alcohol Wet Wipes

Pasion Alcohol Wet Wipes by

Drug Labeling and Warnings

Pasion Alcohol Wet Wipes 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 ALCOHOL WET WIPES- alcohol gel 
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 Alcohol Wet Wipes

Drug Facts

Active ingredient

Ethyl Alcohol 72% (v/v)

Purpose

Antibacterial

Uses

to help reduce bacteria on the skin.

Warnings

For external use only Do not dispose of wipes in flush toilets.

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

Apply to hands or skin. No rinising required. Discard after use.

Other information

Store below 110°F (43°C).
May discolor certain fabrics or surfaces.

Inactive ingredients

Aqua (Water)，Glycerin, Polyquaternium-37, Melaleuca Alternifolia Leaf Oil

Package Labeling:1ct

Package Labeling:20ct

PASION ALCOHOL WET WIPES 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74548-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.72 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74548-015-01	1 in 1 PACKAGE	07/20/2020	09/30/2023
1		5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 74548-015-02	20 in 1 BOX	07/20/2020	09/30/2023
2		5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/20/2020	09/30/2023

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

Revised: 9/2023

Document Id: 0685f812-fa04-815a-e063-6294a90acbae

34390-5

Set id: f3eceea5-5ef8-4f3a-b47b-8a9a972c20bb

Version: 3

Effective Time: 20230929

 

MI