LUBRIMA ALCOHOL WET WIPES- ethyl alcohol cloth 
AGRO GRUP TEKNOLOJI BILGISAYAR SISTEMLERI TEMIZLIK MADDELERI SANAYI VE TICARET LIMITED SIR

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.

----------

​Lubrima ​ALCOHOL WIPES

Drug Facts

Active ingredient

Ethyl Alcohol (80%)

Purpose

Hand Sanitizing

Uses Do not use on eyes and mouth area, temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Warnings

Ask a doctor before use if you have

   • glaucoma

   • a breathing problem such as emphysema or chronic bronchitis

Do NOT dispose in toilet to avoid clogging. Keep in cool place indoors avoid high temperature and direct sunlight. Do NOT throw on fire.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of unexpected symptoms, get medical help or contact a poison Control Center right away.

Directions

Open the cover of the wet wipes or seal the sticker. After use please close the wet wipes cover or seal the sticker to keep the wet wipes moist.

       adults and children 12 years and over   Use as directed
      children 6 years to under 12 years   Use as directed
      children under 6 years   ask a doctor

Other information

• store at 20-25° C (68-77° F)
• protect from excessive moisture

Inactive ingredients

Aqua, Glycerine

%80 ALCOHOL
FORMULATION SAFE FOR HANDS

ALCOHOL CONTENT %80

WARNING

After use please close the seal to prevent water evaporation. Discontinue use if there is any wound, redness, swelling or other discomfort. Wet wipes do not dissolve in water.

PRODUCT FEATURES

Super thick soft cotton touch for increased comfort. Reverse osmosis purified water removes impurities.

Consignor:
A-K Health LLC
520 Robinson LN Unit 4, Wilmington
19805 DE (Delaware)
+1 857 272 4139
EIN: 35-2643785

ISO

GMP

PRODUCT INFORMATION
Name of Commodity: Hand wipes
Product Specification: 140mm x 200mm / 80 Pcs. / Net Weight: 425g / Gross Weight: 450g.
Name of Commodity: Hand wipes
Manufacturer: AGRO GRUP TEKNOLOJI LTD. STI.

Selimpasa Mah. 6093. sk. No: 86/1
Silivri / Istanbul - Türkiye
UBB Record Number: 0080856431
Man. Licence No: 27527096

Packaging

IMAGE

IMAGE

LUBRIMA  ALCOHOL WET WIPES
ethyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80481-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80481-101-0180 in 1 CANISTER08/31/2020
14.20 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/31/2020
Labeler - AGRO GRUP TEKNOLOJI BILGISAYAR SISTEMLERI TEMIZLIK MADDELERI SANAYI VE TICARET LIMITED SIR (533148117)
Establishment
NameAddressID/FEIBusiness Operations
AGRO GRUP TEKNOLOJI BILGISAYAR SISTEMLERI TEMIZLIK MADDELERI SANAYI VE TICARET LIMITED SIR533148117manufacture(80481-101)

Revised: 9/2020
Document Id: 315da0cb-a763-4be6-a874-d4dc14cc4fa0
Set id: e40c6fe0-ec91-4856-b375-c0ffed4be83b
Version: 1
Effective Time: 20200904
 
AGRO GRUP TEKNOLOJI BILGISAYAR SISTEMLERI TEMIZLIK MADDELERI SANAYI VE TICARET LIMITED SIR