OROGIN ESSENTIAL FREE AND CLEAR- alcohol solution

Orogin Essential Free and Clear by

Drug Labeling and Warnings

Orogin Essential Free and Clear by is a Otc medication manufactured, distributed, or labeled by Global Impact Innovation LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 72% v/v. Purpose: Antiseptic

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

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

WHEN USING

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.

STOP USE

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.

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.

Other information

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

Inactive ingredients

Water, Glycerin, Acrylates/C10-30 Alkyl Crylate Crosspolymer, Aminomethyl Propanol, Vitamin E Acetate

Package Label - Principal Display Panel

236 mL NDC: 74588-590-10

473 mL NDC: 74588-590-11

945 mL NDC: 74588-590-12

3.78 L NDC: 74588-590-04

INGREDIENTS AND APPEARANCE

OROGIN ESSENTIAL FREE AND CLEAR 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74588-590
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	170.3436 mL  in 236.588 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	3.4305 mL  in 236.588 mL
WATER (UNII: 059QF0KO0R)	55.6434 mL  in 236.588 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.1183 mL  in 236.588 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	6.7213 mL  in 236.588 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.3312 mL  in 236.588 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74588-590-10	236.588 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
2	NDC: 74588-590-11	473.176 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
3	NDC: 74588-590-12	946.353 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020
4	NDC: 74588-590-04	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/31/2020

Labeler - Global Impact Innovation LLC (117465830)