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Medi Fect

Medi Fect Label

Approved
Approval ID

dc397d9c-9c12-41e5-ab7f-196fcad5bf97

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

Medical Chemical Corporation

DUNS: 008496861

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ethyl Alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code12745-177
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ethyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (7)

CARBOMER HOMOPOLYMER TYPE CInactive
Quantity: 0.5 g in 100 mL
Code: 4Q93RCW27E
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.5 g in 100 mL
Code: 6OZP39ZG8H
Classification: IACT
ALOE VERA LEAFInactive
Quantity: 0.5 g in 100 mL
Code: ZY81Z83H0X
Classification: IACT
DIISOPROPYLAMINEInactive
Quantity: 0.505 g in 100 mL
Code: BR9JLI40NO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLActive
Quantity: 59.86 g in 100 mL
Code: 3K9958V90M
Classification: ACTIB
DIAZOLIDINYL UREAActive
Quantity: 1 g in 100 mL
Code: H5RIZ3MPW4
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/15/2020

medifectlabel.jpg

medifectlabel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/24/2017

Indications for use: For hospital and professional use only. Medi-Fect is intended to be used as a hand-wash to reduce bacteria that can potentially cause disease. Recommended for repeated use.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/24/2017

Indications for use: For hospital and professional use only. Medi-Fect is intended to be used as a hand-wash to reduce bacteria that can potentially cause disease. Recommended for repeated use.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/24/2017

Ingredients: 70% v/v ethyl alcohol, propylene glycol, emolients (polysorbate 80, cetyl alcohol, acetylated lanolin alcohol), carbomer, diazolidinyl urea, methyl paraben, aloe vera and propyl paraben. Contains emollients and skin conditioners. Contains no added fragrance or dyes.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/24/2017

Ingredients: 70% v/v ethyl alcohol, propylene glycol, emolients (polysorbate 80, cetyl alcohol, acetylated lanolin alcohol), carbomer, diazolidinyl urea, methyl paraben, aloe vera and propyl paraben. Contains emollients and skin conditioners. Contains no added fragrance or dyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/24/2017

Warnings: Flammable, keep away from fire or flame. For external use only. Do no use in the eyes. Discontinue use if irritation or redness develops. Keep out of reach of children. In case of ingestion contact poison control center immediately.

WARNINGS SECTION

LOINC: 34071-1Updated: 10/24/2017

Warnings: Flammable, keep away from fire or flame. For external use only. Do no use in the eyes. Discontinue use if irritation or redness develops. Keep out of reach of children. In case of ingestion contact poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/24/2017

Directions: Place a 'palmful' (about 5 g) of product in one hand. Spread on both hands and rub into the skin until dry (approximately 1 to 2 minutes). Place a smaller amount (2.5 grams) into one hand, spread over both hands to wrist, and rub into skin until dry (approximately 30 seconds).

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Medi Fect - FDA Drug Approval Details