LARA MED ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth 
LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI

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.

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LARA MED Antibacterial Wet Wipes

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

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 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

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

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)

Revised: 10/2020
Document Id: b16c27f4-f000-87a8-e053-2995a90a12b6
Set id: a9e8ef10-d00c-b416-e053-2a95a90a77f8
Version: 5
Effective Time: 20201011
 
LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI