FRIDA 70 ALCOHOL PLUS ALOE HAND SANITIZER- ethyl alcohol gel 
Prime Enterprises

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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Frida Hand Sanity 70% Alcohol + Aloe Hand Sanitizer

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Flammable: Do not use near hear, flame or while smoking.

When using this product: Keep put of eyer. If product gets into eyes, rinse with water to remove. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center inmediately.

Directions

Other Information

Inactive ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Glycerin, Isopropyl Myristate, Tocopherol, Water

Questions and comments

fussbuster@frida.com

Frida Hand Sanity 70% Alcohol + Aloe Hand Sanitizer

Principal Display Label

FRIDA  70 ALCOHOL PLUS ALOE HAND SANITIZER
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (Colorless) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0310-3118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/27/2020
Labeler - Prime Enterprises (101946028)
Registrant - Prime Enterprises (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises101946028manufacture(58443-0310) , pack(58443-0310) , label(58443-0310) , analysis(58443-0310)

Revised: 4/2020
Document Id: a4d83a92-8172-5a90-e053-2a95a90a8755
Set id: a4d82814-10d4-5c25-e053-2a95a90a9516
Version: 1
Effective Time: 20200403
 
Prime Enterprises