FLOVELL CARE ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth 
INOSER INSAAT IC 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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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 (0.2%, weight/weight (w/w))
  2. GLYCERYL OLEATE
  3. LAURYL GLUCOSIDE
  4. PANTHENOL
  5. PHENOXYETHANOL
  6. OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER
  7. PROPYLENE GLYCOL
  8. COCAMIDOPROPYL BETAINE
  9. DICAPRYLYL CARBONATE
  10. FATTY-ACID AMIDE HYDROLASE 1
  11. GLYCERIN
  12. ALLANTOIN
  13. WATER
  14. BENZOIC ACID
  15. ANHYDROUS CITRIC ACID
  16. DEHYDROACETIC ACID
  17. ALOE VERA LEAF
  18. POLYSORBATE 20

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 0.2 % ( w/w ) Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Standard usage Antibacterial Wet Wipes: Soak the closed and impermable package inside hot water until it gets warm.

Microwave usage: Heat the package at 750 W for 20 seconds by tag label side openyl.

Antibacterial wet wipes: whenever is necessary and needed, it can be used as 1 piece for patients to wipes.

It is used to celan who is incontinent position in need bath.

Wet wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Do not use

When using this product do not use in or near eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs.

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

Directions

Other information

Inactive ingredients

GLYCERYL OLEATE, LAURYL GLUCOSIDE, PANTHENOL, PHENOXYETHANOL, OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER, PROPYLENE GLYCOL, COCAMIDOPROPYL BETAINE, DICAPRYLYL CARBONATE, FATTY-ACID AMIDE HYDROLASE 1, GLYCERIN, ALLANTOIN, WATER, BENZOIC ACID, ANHYDROUS CITRIC ACID, DEHYDROACETIC ACID
ALOE VERA LEAF, POLYSORBATE 20

Package Label - Principal Display Panel

72 pcs NDC: 86001-001-02

72 pcs

15 pcs NDC 86001-001-04

15 pcs

100 pcs NDC: 86001-001-06

100 PCS

FLOVELL CARE ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86001-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER (UNII: X0S2P50TYC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
FATTY-ACID AMIDE HYDROLASE 1 (UNII: E747F394ZQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
WATER (UNII: 059QF0KO0R)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86001-001-0272 in 1 PACKAGE10/30/2020
1NDC:86001-001-010.008524 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:86001-001-06100 in 1 PACKAGE10/30/2020
2NDC:86001-001-050.008524 g in 1 PATCH; Type 0: Not a Combination Product
3NDC:86001-001-0415 in 1 PACKAGE10/30/2020
3NDC:86001-001-030.008524 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 finalpart333A10/30/2020
Labeler - INOSER INSAAT IC VE DIS TICARET ANONIM SIRKETI (595839639)
Registrant - INOSER INSAAT IC VE DIS TICARET ANONIM SIRKETI (595839639)
Establishment
NameAddressID/FEIBusiness Operations
LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI502977856manufacture(86001-001)

Revised: 12/2020
Document Id: b5cd9feb-f518-60ee-e053-2995a90a3524
Set id: b5c6d3f4-7cff-2e7f-e053-2995a90a0b8e
Version: 2
Effective Time: 20201206
 
INOSER INSAAT IC VE DIS TICARET ANONIM SIRKETI