NIVANA HAND SANITIZER- alcohol gel 
Dinasty Inc.

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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Nivana Hand Sanitizer

Drug Facts

Active ingredient

Ethanol (Ethyl Alcohol)75%v/v

Purpose

Antiseptic

Use

to help reduce bacteria on the skin that could potentially cause disease

Warnings

Flammable, keep away from fire or flame.

For external use only:hands

When using this product

  • do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears and lasts

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

Purified water USP, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Aloe Barbadensis (Aloe Vera) Gel, Tocopheryl Acetate (Vitamin E)

Package Labeling:

Bottle2

NIVANA HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78554-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78554-005-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/11/2020
Labeler - Dinasty Inc. (097919383)

Revised: 10/2020
Document Id: b17df0ed-bcf5-7051-e053-2a95a90a23f3
Set id: b17de090-820f-c05c-e053-2995a90a4c48
Version: 1
Effective Time: 20201012
 
Dinasty Inc.