LUBRIMA ALCOHOL WET WIPES- ethyl alcohol cloth

LUBRIMA by

Drug Labeling and Warnings

LUBRIMA by is a Otc medication manufactured, distributed, or labeled by AGRO GRUP TEKNOLOJI BILGISAYAR SISTEMLERI TEMIZLIK MADDELERI SANAYI VE TICARET LIMITED SIR. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl Alcohol (80%)

Purpose

Hand Sanitizing

INDICATIONS & USAGE

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

SPL UNCLASSIFIED SECTION

%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

INGREDIENTS AND APPEARANCE

LUBRIMA  ALCOHOL WET WIPES
ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80481-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80481-101-01	80 in 1 CANISTER	08/31/2020
1		4.20 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/31/2020

Labeler - AGRO GRUP TEKNOLOJI BILGISAYAR SISTEMLERI TEMIZLIK MADDELERI SANAYI VE TICARET LIMITED SIR (533148117)

Establishment
Name	Address	ID/FEI	Business Operations
AGRO GRUP TEKNOLOJI BILGISAYAR SISTEMLERI TEMIZLIK MADDELERI SANAYI VE TICARET LIMITED SIR		533148117	manufacture(80481-101)