Every Night Hand Sanitizer with Aloe Vera

Every Night Hand Sanitizer with Aloe Vera by

Drug Labeling and Warnings

Every Night Hand Sanitizer with Aloe Vera by is a Otc medication manufactured, distributed, or labeled by Laboratorios Fisa C.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EVERY NIGHT HAND SANITIZER WITH ALOE VERA- alcohol gel 
Laboratorios Fisa C.A.

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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Every Night Hand Sanitizer with Aloe Vera

DRUG FACTS

ACTIVE INGREDIENT(S)

Ethyl Alcohol 70%

PURPOSE

Antiseptic

USES

• Gel for hand washing

WARNINGS

• For external use only.
• Flammable, keep away from heat and flame.

Do not use

• In children less than 2 month 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 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.

INACTIVE INGREDIENTS

• Water, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Aloe barbadensis extract.

Package Labeling:

EVERY NIGHT HAND SANITIZER WITH ALOE VERA 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80483-000
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80483-000-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020	09/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/01/2020	09/23/2021

Labeler - Laboratorios Fisa C.A. (855051376)

Revised: 10/2021

Document Id: cd89c00c-8663-e631-e053-2a95a90ace61

34390-5

Set id: af4b4059-31c8-1ec0-e053-2a95a90a951f

Version: 2

Effective Time: 20211004