PREMIUM HAND SANITIZER GEL- alcohol gel

Premium Hand Sanitizer Gel by

Drug Labeling and Warnings

Premium Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by SOOTSOAP SUPPLY CO LTD, Natures Formulae Health Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions

- Place enough product on hands to cover all surfaces. Rub hands together until dry.

- Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive Ingredients

Purified water, Aloe Barbadensis Leaf Juice Powder, Hydroxyethyl cellulose, Mentha Piperita (Peppermint) Essential Oil

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Keep out of reach of children.

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

Purpose

Antiseptic

Active Ingredient[s]

Alcohol (Ethanol) 70% v/v

Warnings

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

- Do not use in children less than 2 months of age. Do not use in open skin wounds.

- 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIUM HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81524-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
WATER (UNII: 059QF0KO0R)
PEPPERMINT OIL (UNII: AV092KU4JH)

Product Characteristics
Color	gray (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81524-111-01	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2021
2	NDC: 81524-111-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2021
3	NDC: 81524-111-07	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	02/12/2021

Labeler - SOOTSOAP SUPPLY CO LTD (204255801)

Registrant - SOOTSOAP SUPPLY CO LTD (204255801)

Establishment
Name	Address	ID/FEI	Business Operations
Natures Formulae Health Products Ltd.		241385587	manufacture(81524-111)