Zanysan Hand Sanitizer by VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V. Zanysan Hand Sanitizer

Zanysan Hand Sanitizer by

Drug Labeling and Warnings

Zanysan Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZANYSAN HAND SANITIZER- alcohol gel 
VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V.

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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Zanysan Hand Sanitizer

Active Ingredients:

Ethyl Alcohol at 70%

Purpose:

Antiseptic

Uses:

Hand Sanitizer to help reduce germs. For use when soap and water not available

Warning:

For external use only. Flammable. Keep away from open flame and sources of heat or flame.

Do not use:

On children less than 2 months of age. On open skin wounds.

When using this product:

Keep out of eyes, ears and mouth. In case of contact with eyes rinse eyes throughly with water

Stop use and ask doctor:

If irritation or rash occurs. These may be signs of a serious condition

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center right away

Directions:

Apply a small amount of product into hands and rub on both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other information:

Store below 110 ºF (43 ºC). Avoid freezing. May discolor certain fabrics or surfaces.

Inactive Ingredients:

Water, Glycerine, Carbopol, Triethanolamine. 

Package Labeling: 60ml

Package Labeling: 1000ml

ZANYSAN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74967-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74967-002-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020	06/15/2020
2	NDC: 74967-002-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020	06/15/2020

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

Labeler - VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V. (589993745)

Revised: 12/2020

Document Id: b6713cb1-e7c0-962e-e053-2a95a90a40ee

34390-5

Set id: 0bf90f06-570f-415b-9f6b-c28001effe6b

Version: 2

Effective Time: 20201214

 

VAGO I