SAFE CLEAN PROTECTION KIT- ethyl alcohol 75% 
Mimish Designs, LLC

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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Safe+Clean Protection Kit

Active Ingredient

Ethyl Alcohol 75%

­­­­­­­­­­­­­­­­­­­­­ Purpose

Antiseptic

Uses

To help reduce bacteria on skin.

Warnings

For External Use only. Flammable. Keep away from heat or flame.

When using this product

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

­­­­­­­­­­­­­­­­­­­Stop use and ask a doctor.

If irritation or redness develops and last.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

­­­­­­­­­­­­­­­­­­­­­Directions

Squeeze a significant amount in your palm and rub hands until fully dry. Rinse free

Other Information

Store below 110F (43C)

Inactive Ingredients

Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Aminomethyl propanol, Melaleuca Alternifolia Leaf Oil.

Safe+Clean Protective Kit

labellabellabel

SAFE CLEAN PROTECTION KIT 
ethyl alcohol 75% kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79312-103
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79312-103-041 in 1 KIT; Type 1: Convenience Kit of Co-Package05/01/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH 1 mL
Part 21 POUCH 1 
Part 1 of 2
SAFE CLEAN HAND SANITIZER 
ethyl alcohol 75% gel
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL1.125 mL  in 1.5 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
WATER (UNII: 059QF0KO0R)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
GLYCERIN (UNII: PDC6A3C0OX)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79312-101-011.5 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/2020
Part 2 of 2
SAFE CLEAN ALCOHOL WET WIPE 
ethyl alcohol 75% swab
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYQUATERNIUM 37 (200 MPA.S) (UNII: 67C1D6YV24)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79312-102-011 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/2020
Labeler - Mimish Designs, LLC (131433402)
Registrant - Mimish Designs, LLC (131433402)

Revised: 7/2020
Document Id: aa04e977-c31a-7d44-e053-2a95a90a52ec
Set id: aa051319-09f6-57d5-e053-2a95a90adee2
Version: 1
Effective Time: 20200709
 
Mimish Designs, LLC