NATURAL- antibacterial gel

NATURAL by

Drug Labeling and Warnings

NATURAL by is a Otc medication manufactured, distributed, or labeled by INTERNATIONAL GENERAL TRADING CORP, House and Beauty Care México, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

BENZALKONIUM CHLORIDE

Purpose

Antibacterial

Use

FOR HANDWASHING TO DECREASE BATERIA ON THE SKIN

Warnings

For external use only.

Do not use

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

WHEN USING

When using this product do not get into yes. If contact occurs rinse eye throughly with water

STOP USE

stop use and ask a docor if irritation or redness develops

KEEP OUT OF REACH OF CHILDREN

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

Directions

Wash hands, apply palful to hhand rub thoughly and rinse

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

WATER, SODIUM LAURYLETHER SULFATHEM COCOAMIDO PROPYL, BETAINE, GLYCERIN, ESSENTIAL OILS, SODIUM CHORIDE, COLLAGEN. SODIUMFEINT, SALT, ALOE VERA, YELLOW#5 d&c, RED#4 D&C

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

NATURAL 
antibacterial gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78440-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78440-001-01	1892 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
2	NDC: 78440-001-03	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
3	NDC: 78440-001-02	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
4	NDC: 78440-001-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020
5	NDC: 78440-001-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/13/2020

Labeler - INTERNATIONAL GENERAL TRADING CORP (825499598)

Registrant - INTERNATIONAL GENERAL TRADING CORP (825499598)

Establishment
Name	Address	ID/FEI	Business Operations
House and Beauty Care México, S.A. de C.V.		812821623	api manufacture(78440-001)

Establishment
Name	Address	ID/FEI	Business Operations
INTERNATIONAL GENERAL TRADING CORP		825499598	relabel(78440-001)