FLOVELL CARE ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

FLOVELL CARE ANTIBACTERIAL WET WIPES by

Drug Labeling and Warnings

FLOVELL CARE ANTIBACTERIAL WET WIPES by is a Otc medication manufactured, distributed, or labeled by INOSER INSAAT IC VE DIS TICARET ANONIM SIRKETI, LARA KOZMETIK HIJYENIK URUNLERI SANAYI VE DIS TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (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

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

STOP USE

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

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 wipe 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 temperature.
• Do not flush down toilet.

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

15 pcs NDC: 86001-001-04

100 pcs NDC: 86001-001-06

INGREDIENTS AND APPEARANCE

FLOVELL CARE ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth

Product 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)