FDA Label for Flovell Care Antibacterial Wet Wipes
View Indications, Usage & Precautions
Flovell Care Antibacterial Wet Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Inoser Insaat Ic Ve Dis Ticaret Anonim Sirketi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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)
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
Otc - When Using
When using this product do not use in or near eyes. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs.
Otc - 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
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