MEDI FECT ANTISEPTIC HAND WASH- ethyl alcohol liquid

Medi Fect by

Drug Labeling and Warnings

Medi Fect by is a Otc medication manufactured, distributed, or labeled by Medical Chemical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

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.

ACTIVE INGREDIENT

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

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.

KEEP OUT OF REACH OF CHILDREN

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

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

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).

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

medifectlabel.jpg

INGREDIENTS AND APPEARANCE

MEDI FECT   ANTISEPTIC HAND WASH
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12745-177
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	59.86 g  in 100 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) (DIAZOLIDINYL UREA - UNII:H5RIZ3MPW4)	DIAZOLIDINYL UREA	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)	0.5 g  in 100 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	0.5 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.5 g  in 100 mL
DIISOPROPYLAMINE (UNII: BR9JLI40NO)	0.505 g  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12745-177-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/14/2001
2	NDC: 12745-177-02	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/14/2001
3	NDC: 12745-177-03	3785 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	05/14/2001
4	NDC: 12745-177-04	18927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/14/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/14/2001

Labeler - Medical Chemical Corporation (008496861)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Chemical Corporation		008496861	manufacture(12745-177)