HYGIEE HAND SANITIZER- ethyl alcohol gel

HYGIEE Hand sanitizer by

Drug Labeling and Warnings

HYGIEE Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by AL SAFI CHEMICALS IND LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

Uses

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

in children less than 2 months of age
on 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.

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 at 1-800-222-1222.

Direction

• 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.

SPL UNCLASSIFIED SECTION

Other information

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

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Product labels

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYGIEE HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81299-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81299-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020
2	NDC: 81299-001-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020
3	NDC: 81299-001-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020
4	NDC: 81299-001-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020
5	NDC: 81299-001-05	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020
6	NDC: 81299-001-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020
7	NDC: 81299-001-07	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/01/2020

Labeler - AL SAFI CHEMICALS IND LLC (851676190)

Establishment
Name	Address	ID/FEI	Business Operations
AL SAFI CHEMICALS IND LLC		851676190	manufacture(81299-001)