MEDI FECT ANTISEPTIC HAND WASH- ethyl alcohol liquid 
Medical Chemical Corporation

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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Medi Fect Label

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.

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.

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.

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: 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.

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 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.

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medifectlabel

MEDI FECT  ANTISEPTIC HAND WASH
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12745-177
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL59.86 g  in 100 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) (DIAZOLIDINYL UREA - UNII:H5RIZ3MPW4) DIAZOLIDINYL UREA1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12745-177-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
2NDC:12745-177-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
3NDC:12745-177-033785 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package05/14/2001
4NDC:12745-177-0418927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
5NDC:12745-177-0559 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
6NDC:12745-177-06237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
7NDC:12745-177-07946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2001
8NDC:12745-177-08208198 mL in 1 DRUM; Type 0: Not a Combination Product05/14/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/14/2001
Labeler - Medical Chemical Corporation (008496861)
Establishment
NameAddressID/FEIBusiness Operations
Medical Chemical Corporation008496861manufacture(12745-177)

Revised: 10/2020
Document Id: b1bcc2dc-09d1-14d6-e053-2a95a90af9d1
Set id: dc397d9c-9c12-41e5-ab7f-196fcad5bf97
Version: 14
Effective Time: 20201015
 
Medical Chemical Corporation