Label: FLOVELL CARE ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 86001-001-01, 86001-001-02, 86001-001-03, 86001-001-04, view more86001-001-05, 86001-001-06 - Packager: INOSER INSAAT IC 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 December 6, 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 (0.2%, weight/weight (w/w))
- 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
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 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
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
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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
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INGREDIENTS AND APPEARANCE
FLOVELL CARE ANTIBACTERIAL WET WIPES
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:86001-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.2 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:86001-001-02 72 in 1 PACKAGE 10/30/2020 1 NDC:86001-001-01 0.008524 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:86001-001-06 100 in 1 PACKAGE 10/30/2020 2 NDC:86001-001-05 0.008524 g in 1 PATCH; Type 0: Not a Combination Product 3 NDC:86001-001-04 15 in 1 PACKAGE 10/30/2020 3 NDC:86001-001-03 0.008524 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 10/30/2020 Labeler - INOSER INSAAT IC VE DIS TICARET ANONIM SIRKETI (595839639) Registrant - INOSER INSAAT IC VE DIS TICARET ANONIM SIRKETI (595839639) Establishment Name Address ID/FEI Business Operations LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI 502977856 manufacture(86001-001)
