OTC Medication Information: Safe Clean Protection Kit

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.

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

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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 Multilevel Packaging
1 NDC:79312-103-04 1 KIT in 1 KIT None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 1.125 mL in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
PHENOXYETHANOL
AMINOMETHYL PROPANEDIOL
WATER
MELALEUCA ALTERNIFOLIA LEAF
GLYCERIN
(C10-C30)ALKYL METHACRYLATE ESTER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79312-101-01 1.5 mL in 1 POUCH None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.75 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
POLYQUATERNIUM 37 (200 MPA.S)
MELALEUCA ALTERNIFOLIA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79312-102-01 1 SWAB in 1 POUCH None
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)

Revised: 07/2020 Mimish Designs, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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