Hand Sanitizer by Desaviesa Mundial S. De R.L De C.V Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Desaviesa Mundial S. De R.L De C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Desaviesa Mundial S. De R.L 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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Hand Sanitizer

Drug Facts:

Active ingredients

Ethyl Alcohol 75%

purpose

Antiseptic

Use:

Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only.

Flammable. Keep away from heat and flame.

Do not use.

- in childrens 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 thoroughly with water.

Stop use and ask a 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

- Place enough product on hands to cover all surfaces. Rub hands together until dry.

- Supervise children under 6 years of age when using this producct to avoid swallowing.

Other information

- Store between 15-30C (59-86F)

- Avoid Freezing and excessive heat above 40C (140F)

Inactive ingredients

Glycerin, Carbomer, Distilled water.

Package Labeling:78455-000-01 60mL

Package Labeling:78455-000-02, 4L

Package Labeling:78455-000-03, 200L

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78455-000
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
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78455-000-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020	08/05/2020
2	NDC: 78455-000-02	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020	08/05/2020
3	NDC: 78455-000-03	200000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2020	08/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/26/2020	08/05/2020

Labeler - Desaviesa Mundial S. De R.L De C.V (951578386)

Establishment
Name	Address	ID/FEI	Business Operations
Desaviesa Mundial S. De R.L De C.V		951578386	manufacture(78455-000)

Revised: 9/2020

Document Id: b05d4b7e-1e92-14ab-e053-2995a90a6755

34390-5

Set id: eef1a399-4770-49d2-832c-25da0e6fbe0e

Version: 2

Effective Time: 20200928