SAFE CLEAN PROTECTION KIT- ethyl alcohol 75% kit

Safe Clean Protection Kit by

Drug Labeling and Warnings

Safe Clean Protection Kit by is a Otc medication manufactured, distributed, or labeled by Mimish Designs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SAFE CLEAN PROTECTION KIT 
ethyl alcohol 75% kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79312-103

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79312-103-04	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	05/01/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	1 mL
Part 2	1 POUCH	1

Part 1 of 2

SAFE CLEAN HAND SANITIZER 
ethyl alcohol 75% gel

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	1.125 mL  in 1.5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79312-101-01	1.5 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Part 2 of 2

SAFE CLEAN ALCOHOL WET WIPE 
ethyl alcohol 75% swab

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYQUATERNIUM 37 (200 MPA.S) (UNII: 67C1D6YV24)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79312-102-01	1 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Labeler - Mimish Designs, LLC (131433402)

Registrant - Mimish Designs, LLC (131433402)