ANTIMICROBIAL HAND SANITIZER- alcohol gel 
NVIP LLC

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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Antimicrobial Hand Sanitizer

Drug Facts

Active ingredient

Alcohol 70% v/v

Purpose

Antimicrobial

Use[s]

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.

For External use only.

Do not use

  • on children less than 2 months of age
  • on open skin wounds

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

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, PEG-12 Dimethicone, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate.

Other information

80182-001-12

Bottle

80182-001-16

Bottle2

ANTIMICROBIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76939-555
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76939-555-12350 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
2NDC:76939-555-16475 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/15/2020
Labeler - NVIP LLC (117497228)

Revised: 8/2020
Document Id: ad543603-1b74-8d1c-e053-2a95a90a830e
Set id: ad545737-d113-3d94-e053-2995a90adeee
Version: 1
Effective Time: 20200820
 
NVIP LLC