KANECHOM- alcohol antiseptic 80% solution 
SNC Indústria de Cosméticos Ltda

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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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)

Alcohol 80% v/v.

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.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

169.07 FL.OZ (5L) NDC: 79990-112-05

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KANECHOM 
alcohol antiseptic 80% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79990-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.450 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 18.425 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79990-112-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
2NDC:79990-112-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
3NDC:79990-112-03250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
4NDC:79990-112-04500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
5NDC:79990-112-055000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/03/2020
Labeler - SNC Indústria de Cosméticos Ltda (914610642)
Establishment
NameAddressID/FEIBusiness Operations
SNC Indústria de Cosméticos Ltda914610642manufacture(79990-112)

Revised: 8/2020
Document Id: 07f4ce0f-334e-4fef-b91f-b1b18aa78a9e
Set id: ac97519b-47f4-435b-954d-e0c29039057d
Version: 1
Effective Time: 20200803
 
SNC Indústria de Cosméticos Ltda