Label: LUBRIMA ALCOHOL WET WIPES- ethyl alcohol cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 80481-101-01 - Packager: AGRO GRUP TEKNOLOJI BILGISAYAR SISTEMLERI TEMIZLIK MADDELERI SANAYI VE TICARET LIMITED SIR
- 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 September 4, 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
- INDICATIONS & USAGE
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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.
- Directions
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
%80 ALCOHOL
FORMULATION SAFE FOR HANDSALCOHOL 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: 35-2643785ISO
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
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INGREDIENTS AND APPEARANCE
LUBRIMA ALCOHOL WET WIPES
ethyl alcohol clothProduct 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)
