Label: ANTISEPTIC HAND SANITIZER- alcohol liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 79455-001-01, 79455-001-02, 79455-001-03, 79455-001-04, view more79455-001-05, 79455-001-06, 79455-001-07, 79455-001-08, 79455-001-09, 79455-001-10, 79455-001-11, 79455-001-12 - Packager: NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- 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 woundsWhen using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
- irritation and redness develop
- condition persists for more than 72 hours
- Directions
- Other information
- Inactive ingredients
-
SPL UNCLASSIFIED SECTION
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 34920COUNTRY OF ORIGIN: TURKEY
- Packaging
-
INGREDIENTS AND APPEARANCE
ANTISEPTIC HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79455-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 L in 100 L Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) LANOLIN (UNII: 7EV65EAW6H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79455-001-01 0.03 L in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020 2 NDC:79455-001-02 0.05 L in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020 3 NDC:79455-001-03 0.1 L in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020 4 NDC:79455-001-04 0.25 L in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020 5 NDC:79455-001-05 0.5 L in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020 6 NDC:79455-001-06 0.7 L in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020 7 NDC:79455-001-07 1 L in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020 8 NDC:79455-001-08 2 L in 1 BOTTLE; Type 0: Not a Combination Product 07/13/2020 9 NDC:79455-001-09 5 L in 1 CAN; Type 0: Not a Combination Product 07/13/2020 10 NDC:79455-001-10 10 L in 1 CAN; Type 0: Not a Combination Product 07/13/2020 11 NDC:79455-001-11 20 L in 1 DRUM; Type 0: Not a Combination Product 07/13/2020 12 NDC:79455-001-12 30 L in 1 DRUM; Type 0: Not a Combination Product 07/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/13/2020 Labeler - NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI (355742649) Establishment Name Address ID/FEI Business Operations NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI 355742649 manufacture(79455-001)
