INSTANT HAND SANITIZER- alcohol gel 
Zidac Laboratories Ltd

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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Instant Hand Sanitizer

DRUG FACTS

Active Ingredient

Ethyl Alcohol 77%v/v

Purpose

Antimicrobial

Uses

Warnings

Flammable. Keep away from fire or flame. For external use only.

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 occurs and lasts.

Keep out of reach of children.

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

Directions

Storage

Store below 110°F (43°C)

Inactive ingredients

Water (Aqua), Glycerin, Carbomer, Aminomethyl Propanol, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Propylene Glycol

Package Labeling: 100ml

Bottle

Package Labeling: 500ml

Bottle2

Package Labeling:5000ml

Label

INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79699-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.77 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79699-000-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
2NDC:79699-000-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
3NDC:79699-000-195000 mL in 1 CAN; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/2020
Labeler - Zidac Laboratories Ltd (222761253)

Revised: 10/2020
Document Id: b0b4dadd-11da-3dbb-e053-2995a90a2097
Set id: ab70bc49-b5a0-cd46-e053-2a95a90a5ce7
Version: 2
Effective Time: 20201002
 
Zidac Laboratories Ltd