CORNELLS by Premier Cosmetics CORNELLS- alcohol gel

CORNELLS by

Drug Labeling and Warnings

CORNELLS by is a Otc medication manufactured, distributed, or labeled by Premier Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Isopropyl Alcohol 70% v/v.   

Purpose

Antiseptic

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 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.

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 15-300C (59-860F)
• Avoid freezing and excessive heat above 400C (1040F)

Inactive ingredients

Aqua, Glycerin, Propylene Glycol, Isopropyl Myristate, Aminomethyl Propanol, Carbomer, Fragrance, Tocopheryl Acetate, Aloe barbadensis Leaf Extract.

Package Label - Principal Display Panel

Label 65 mL

Label 480 mL

Label 500 mL

Label 1000 mL

INGREDIENTS AND APPEARANCE

CORNELLS 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78117-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78117-001-01	65 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/02/2020
2	NDC: 78117-001-02	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/02/2020
3	NDC: 78117-001-03	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/02/2020
4	NDC: 78117-001-04	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/02/2020

Labeler - Premier Cosmetics (557941540)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Cosmetics		557941540	manufacture(78117-001)