Label: LARA MED ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 86994-004-06, 86994-004-07, 86994-004-08, 86994-004-09, view more86994-004-10, 86994-004-11, 86994-004-12, 86994-004-13, 86994-004-14, 86994-004-15, 86994-004-16, 86994-004-17 - Packager: LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM 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 October 11, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Benzalkonium Chloride (USP or Food Chemical Codex (FCC) grade) (0.15%, weight/weight (w/w)) in an aqueous solution denatured Trade Bureau regulations in 27 CFR part 20
- ALLANTOIN,
- ALOE BARBADENSIS LEAF JUICE,
- BENZOIC ACID,
- CITRIC ACID,
- COCAMIDOPROPYL BETAINE,
- DEHYDROACETIC ACID,
- DICAPRYLYL CARBONATE,
- GLYCERIN,
- GLYCERYL OLEATE,
- LAURYL GLUCOSIDE,
- OLUS OIL,
- PANTHENOL,
- PARFUM,
- PHENOXYETHANOL,
- POLYGLYCERYL-2-DIPOLYHYDROXYSTEARATE,
- POLYSORBATE 20,
- PROPYLENE GLYCOL,
- WATER
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- Active Ingredient(s)
- Purpose
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Use
Standard usage Antibacterial wet wipes; soak the closed and impermeable package inside hot water until it gets warm. Microwave usage: Heat the package at 750 W for seconds by lag label side openly.
Antibacterial Wet wipes: Whenever is necessary and needed, it can be used as 1 piece for patients to wipe.It is used to clean who is incontinent position in need bath.
Wet Wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
- Warnings
- Do not use
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WHEN USING
When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
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Inactive ingredients
ALLANTOIN, ALOE BARBADENSIS LEAF JUICE, BENZOIC ACID, CITRIC ACID, COCAMIDOPROPYL BETAINE, DEHYDROACETIC ACID, DICAPRYLYL CARBONATE, GLYCERIN, GLYCERYL OLEATE, LAURYL GLUCOSIDE, OLUS OIL, PANTHENOL, PARFUM, PHENOXYETHANOL, POLYGLYCERYL-2-DIPOLYHYDROXYSTEARATE, POLYSORBATE 20, PROPYLENE GLYCOL, WATER
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
LARA MED ANTIBACTERIAL WET WIPES
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:86994-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.15 g in 100 g Inactive Ingredients Ingredient Name Strength DEHYDROACETIC ACID (UNII: 2KAG279R6R) 0.0525 g in 100 g LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) 0.06 g in 100 g PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.0375 g in 100 g CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.0225 g in 100 g ALLANTOIN (UNII: 344S277G0Z) 0.06 g in 100 g DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) 0.01 g in 100 g BENZOIC ACID (UNII: 8SKN0B0MIM) 0.091 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 0.135 g in 100 g PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.588 g in 100 g WATER (UNII: 059QF0KO0R) 97.911 g in 100 g POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.225 g in 100 g ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0375 g in 100 g GLYCERYL OLEATE (UNII: 4PC054V79P) 0.01 g in 100 g POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) 0.06 g in 100 g DEXPANTHENOL (UNII: 1O6C93RI7Z) 0.15 g in 100 g COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 0.15 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86994-004-11 50 in 1 PACKAGE 03/30/2020 1 NDC:86994-004-10 0.06885 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:86994-004-07 15 in 1 PACKAGE 03/30/2020 2 NDC:86994-004-06 0.03285 g in 1 PATCH; Type 0: Not a Combination Product 3 NDC:86994-004-13 80 in 1 PACKAGE 03/30/2020 3 NDC:86994-004-12 0.0552 g in 1 PATCH; Type 0: Not a Combination Product 4 NDC:86994-004-15 120 in 1 PACKAGE 03/30/2020 4 NDC:86994-004-14 0.0552 g in 1 PATCH; Type 0: Not a Combination Product 5 NDC:86994-004-09 24 in 1 PACKAGE 03/30/2020 5 NDC:86994-004-08 0.0139 g in 1 PATCH; Type 0: Not a Combination Product 6 NDC:86994-004-17 100 in 1 PACKAGE 03/30/2020 6 NDC:86994-004-16 0.0552 g in 1 PATCH; 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 03/30/2020 Labeler - LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI (502977856) Registrant - LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI (502977856) Establishment Name Address ID/FEI Business Operations LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI 502977856 manufacture(86994-004)
