CORNELLS- alcohol liquid 
Premier Cosmetics

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Isopropyl alcohol 70% 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

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.

Directions

Other information

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

Inactive ingredients

Aqua, Glycerin, Propylene Glycol, Isopropyl Myristate, Benzalkonium Chloride, Fragrance, Tocopheryl Acetate, Aloe barbadensis Leaf Extract.

Package Label - Principal Display Panel

Label 100 mL

Label1

CORNELLS 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78117-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78117-004-01100 mL in 1 CAN; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Premier Cosmetics (557941540)
Establishment
NameAddressID/FEIBusiness Operations
Premier Cosmetics557941540manufacture(78117-004)

Revised: 6/2020
Document Id: 8021b527-3907-4979-8ef3-b47a50446981
Set id: 7586a169-b3f8-4083-9fa6-ca74933f76ba
Version: 1
Effective Time: 20200601
 
Premier Cosmetics