ANTISEPTIC HAND SANITIZER- alcohol liquid 
NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI

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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BiORAD DERM ANTISEPTIC HAND SANITIZER

Drug Facts

Active ingredient

Alcohol 70%

Purpose

Antiseptic

Uses

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use
• in children less than 2 months of age
• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

1,3-butandiol, glycerin, isopropyl alcohol, lanolin, fragrance, water

Import Company: Purple Dice LLC

+1-971-235-1506

Monday-Friday 9:00 AM - 5:00 PM

Manufactured by: NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED
SIRKETI, AYTOP GIDA SITE I BLOK, NO:14-1 B GAZI MAHALLESI SARK CADDESI GULGONCASI SOKAK,
SULTANBEYLI, Istanbul (Anatolia), Turkey 34920

COUNTRY OF ORIGIN: TURKEY

Packaging

Sntzr1

ANTISEPTIC HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79455-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LANOLIN (UNII: 7EV65EAW6H)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79455-001-010.03 L in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
2NDC:79455-001-020.05 L in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
3NDC:79455-001-030.1 L in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
4NDC:79455-001-040.25 L in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
5NDC:79455-001-050.5 L in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
6NDC:79455-001-060.7 L in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
7NDC:79455-001-071 L in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
8NDC:79455-001-082 L in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
9NDC:79455-001-095 L in 1 CAN; Type 0: Not a Combination Product07/13/2020
10NDC:79455-001-1010 L in 1 CAN; Type 0: Not a Combination Product07/13/2020
11NDC:79455-001-1120 L in 1 DRUM; Type 0: Not a Combination Product07/13/2020
12NDC:79455-001-1230 L in 1 DRUM; Type 0: Not a Combination Product07/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/13/2020
Labeler - NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI (355742649)
Establishment
NameAddressID/FEIBusiness Operations
NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI355742649manufacture(79455-001)

Revised: 7/2020
Document Id: 51264530-80e9-4595-a753-5f999bb8e578
Set id: bdba6f74-9455-464d-9e75-b5b005b5c9e1
Version: 1
Effective Time: 20200710
 
NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI