NATURAL SENSE- antibacterial aerosol, spray 
INTERNATIONAL GENERAL TRADING CORP

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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NATURAL SENSE SPRAY

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)

ETHYL ALCOHOL 75%

Purpose

Antiseptic, Hand Sanitizer

Use

Decreases bacteria on skin

Recommended for repeat use

Warnings

-Extremely flammable aerosol, keep away from fire and flame

-Keep away from heat, hot surfaces, open flames and other ignition sources

-Pressurized container. Do not pierce or burn even after use

-Protect from sunlight

-For external use only

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.

-IRRITATION PERSIST

OR IF PRODUCT IS SWALLOWED

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

-SHAKE WELL BEFORE USE

HOLD CAN UPRIGHT AT 6-7 INCHES AWAY FROM SURFACE AND SPRAY EVENLY

ALLOW TO AIR DRY FOR 5-10 MINUTS REPEAT IF NECCESARRY

SUPERVISE CHILDREN UNDER 6 YEARS

Other information

Inactive ingredients

BUTANE, PROPANE, ISO BUTANE, FRAGANCE

Package Label - Principal Display Panel

LEMON550 ML 78440-001-01

NATURAL SENSE 
antibacterial aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78440-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPANE (UNII: T75W9911L6) 6.22 mL  in 100 mL
ISOBUTANE (UNII: BXR49TP611) 4.345 mL  in 100 mL
BUTANE (UNII: 6LV4FOR43R) 14 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78440-002-01550 mL in 1 CAN; Type 0: Not a Combination Product09/21/2020
2NDC:78440-002-02550 mL in 1 CAN; Type 0: Not a Combination Product09/21/2020
3NDC:78440-002-03550 mL in 1 CAN; Type 0: Not a Combination Product09/21/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/21/2020
Labeler - INTERNATIONAL GENERAL TRADING CORP (825499598)
Registrant - INTERNATIONAL GENERAL TRADING CORP (825499598)
Establishment
NameAddressID/FEIBusiness Operations
COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI595671824manufacture(78440-002)
Establishment
NameAddressID/FEIBusiness Operations
INTERNATIONAL GENERAL TRADING CORP825499598manufacture(78440-002)

Revised: 9/2020
Document Id: afd1d070-ab48-c890-e053-2995a90a9a0d
Set id: afd1d0be-40c8-7e66-e053-2a95a90a65a1
Version: 1
Effective Time: 20200921
 
INTERNATIONAL GENERAL TRADING CORP