Label: DEEP FRESH ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth
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NDC Code(s):
86815-003-01,
86815-003-02,
86815-003-03,
86815-003-04, view more86815-003-05, 86815-003-06, 86815-003-07, 86815-003-08, 86815-003-09, 86815-003-10
- Packager: AKSAN KOZMETIK SANAYI VE 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 April 8, 2022
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 (0.23%, weight/weight (w/w)
- Dehydroacetic Acid
- Benzoic Acid
- Lauryl Glucoside
- Glycerin
- Propylene Glycol
- Etidronate Tetrasodium
- Octadecanoıc Acid, (Octadecylimıno)Di-2,1-Ethanediyl Ester
- Fatty-Acid Amide Hydrolase 1
- Phenoxyethanol
- Dicaprylyl Carbonate
- Glyceryl Oleate
- Polysorbate 20
- Sterile distilled water or boiled cold 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)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When Using this product do not inhale the vapour or grains of the product if occurs. Do not eat or drink or smoke while using the product. Follow all the instructions to avoid risks on human and environmental health. In case of inhaling: Give fresh air or oxygen. If you feel unwell, consult a doctor. In case of skin contact: This product is produced to contact with the skin. Seek a doctor if redness, swelling, itching, or burning occurs on skin. In case of contact with eyes:If you are wearing contact lenses,remove them immediately.Rinse your eyes with plenty of clean water. In case of swallowing: Rinse mouth. Do not vomiting. If unconscious, never give anything by mouth. If it is vomiting, do not lay it on its back and lay it on its side. Call your local Toxication Center and get medical help.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
DEEP FRESH ANTIBACTERIAL WET WIPES
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:86815-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.23 g in 100 g Inactive Ingredients Ingredient Name Strength POLYSORBATE 20 (UNII: 7T1F30V5YH) DEHYDROACETIC ACID (UNII: 2KAG279R6R) BENZOIC ACID (UNII: 8SKN0B0MIM) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER (UNII: X0S2P50TYC) FATTY-ACID AMIDE HYDROLASE 1 (UNII: E747F394ZQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) GLYCERYL OLEATE (UNII: 4PC054V79P) ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86815-003-01 100 g in 1 POUCH; Type 0: Not a Combination Product 03/30/2020 2 NDC:86815-003-02 15 g in 1 POUCH; Type 0: Not a Combination Product 03/30/2020 3 NDC:86815-003-04 80 in 1 CANISTER 03/30/2020 3 NDC:86815-003-03 0.238464 g in 1 PATCH; Type 0: Not a Combination Product 4 NDC:86815-003-06 100 in 1 CANISTER 03/30/2020 4 NDC:86815-003-05 0.29808 g in 1 PATCH; Type 0: Not a Combination Product 5 NDC:86815-003-08 160 in 1 CANISTER 03/30/2020 5 NDC:86815-003-07 0.4769 g in 1 PATCH; Type 0: Not a Combination Product 6 NDC:86815-003-10 500 in 1 CANISTER 03/30/2020 6 NDC:86815-003-09 1.4904 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 03/30/2020 Labeler - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706) Registrant - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706) Establishment Name Address ID/FEI Business Operations AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI 365577706 manufacture(86815-003)