Label: LARA MED ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

  • NDC Code(s): 86994-004-06, 86994-004-07, 86994-004-08, 86994-004-09, view more
    86994-004-10, 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.

  • 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:

    1. 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
    2. ALLANTOIN,
    3. ALOE BARBADENSIS LEAF JUICE,
    4. BENZOIC ACID,
    5. CITRIC ACID,
    6. COCAMIDOPROPYL BETAINE,
    7. DEHYDROACETIC ACID,
    8. DICAPRYLYL CARBONATE,
    9. GLYCERIN,
    10. GLYCERYL OLEATE,
    11. LAURYL GLUCOSIDE,
    12. OLUS OIL,
    13. PANTHENOL,
    14. PARFUM,
    15. PHENOXYETHANOL,
    16. POLYGLYCERYL-2-DIPOLYHYDROXYSTEARATE,
    17. POLYSORBATE 20,
    18. PROPYLENE GLYCOL,
    19. 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)

    Benzalkonium Chloride 0.15% w/w. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • 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

    For external use only. If irritation occurs, discontinue use.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
    • if you are allergic to chlorhexidine gluconate or any other ingredients.
  • 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

    Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Open package, remove one wet wipes to clean your hands and body. Reseal, keep closed to prevent evaporation. Allow to dry without wiping. Discard properly after use.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store at room temparature.
    • Do not flush down toilet.
  • 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

    24 pcs

    120 pcs

    15 pcs

    80 pcs

    50 pcs

  • INGREDIENTS AND APPEARANCE
    LARA MED ANTIBACTERIAL WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86994-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86994-004-1150 in 1 PACKAGE03/30/2020
    1NDC:86994-004-100.06885 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:86994-004-0715 in 1 PACKAGE03/30/2020
    2NDC:86994-004-060.03285 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:86994-004-1380 in 1 PACKAGE03/30/2020
    3NDC:86994-004-120.0552 g in 1 PATCH; Type 0: Not a Combination Product
    4NDC:86994-004-15120 in 1 PACKAGE03/30/2020
    4NDC:86994-004-140.0552 g in 1 PATCH; Type 0: Not a Combination Product
    5NDC:86994-004-0924 in 1 PACKAGE03/30/2020
    5NDC:86994-004-080.0139 g in 1 PATCH; Type 0: Not a Combination Product
    6NDC:86994-004-17100 in 1 PACKAGE03/30/2020
    6NDC:86994-004-160.0552 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    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
    NameAddressID/FEIBusiness Operations
    LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI502977856manufacture(86994-004)