Sunsent visage by MEFALSA MEDICAMENTOS Y FARMACOS DE LEON

Sunsent visage by

Drug Labeling and Warnings

Sunsent visage by is a Otc medication manufactured, distributed, or labeled by MEFALSA MEDICAMENTOS Y FARMACOS DE LEON. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNSENT VISAGE- hand sanitizer gel gel 
MEFALSA MEDICAMENTOS Y FARMACOS DE LEON

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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Purpose

Antiseptic, Hand sanitizer

Active Ingredients

Isopropyl alcohol 80% v/v

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

Flammable, keep away from fire and flames

For external use only

Do not use

• In 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 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 at 1-800-222-1222

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 product to avoid swallowing.

Other information

• Store between 15 - 30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP.

Package label. Principal display panel

60 mL NDC: 9515-0002-01

Package label. Principal display panel

250 mL NDC: 9515-0002-02

SUNSENT VISAGE 
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 9515-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	10 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	7 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	3 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 9515-0002-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2020	11/30/2020
2	NDC: 9515-0002-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2020	11/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/26/2020	11/30/2020

Labeler - MEFALSA MEDICAMENTOS Y FARMACOS DE LEON (951583455)

Registrant - MEFALSA MEDICAMENTOS Y FARMACOS DE LEON (951583455)

Establishment
Name	Address	ID/FEI	Business Operations
MEFALSA MEDICAMENTOS Y FARMACOS DE LEON		951583455	manufacture(9515-0002) , label(9515-0002)

Revised: 10/2021

Document Id: cf822143-89e4-1eba-e053-2995a90aa820

34390-5

Set id: b4fcc71b-8035-cf78-e053-2995a90a4b50

Version: 3

Effective Time: 20211029