HAND SANITIZER- isopropyl alcohol gel 
KARSOF SYSTEMS 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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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

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.

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

Other information

Inactive ingredients

elettaria cardamomum, azadirachta indica, syzygium aromaticum, cinnamomum camphora, aloe vera, phyllanthus emblica, carbomer, glycerin, hydrogen peroxide, purified water USP, rosa gallica, crocus sativus

Package Label - Principal Display Panel

473.176 ml NDC: 77160-006-01 16oz 473ml label

946.353 ml NDC: 77160-006-02 32oz 946ml label

3785.41 ml NDC: 77160-006-03 128oz 3785ml label

HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77160-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ROSA GALLICA FLOWER OIL (UNII: B3Y66352HF)  
ELETTARIA CARDAMOMUM WHOLE (UNII: KH2S76267N)  
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
SYZYGIUM AROMATICUM WHOLE (UNII: EY9MMA0P6Y)  
CINNAMOMUM CAMPHORA WHOLE (UNII: 0B27814T7X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CROCUS SATIVUS FLOWER (UNII: 00IF91KFKQ)  
PHYLLANTHUS EMBLICA WHOLE (UNII: 9B45E1E94Z)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77160-007-01473.176 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/11/2020
2NDC:77160-007-02946.353 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
3NDC:77160-007-033785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/11/2020
Labeler - KARSOF SYSTEMS LLC (049125501)
Registrant - KARSOF SYSTEMS LLC (049125501)
Establishment
NameAddressID/FEIBusiness Operations
KARSOF SYSTEMS LLC049125501manufacture(77160-007)

Revised: 5/2020
Document Id: a513bd3f-8bbe-ab81-e053-2995a90a7b49
Set id: a513bd3f-8bbc-ab81-e053-2995a90a7b49
Version: 1
Effective Time: 20200507
 
KARSOF SYSTEMS LLC