WhiteDay Antibacterial Wet Towels

WhiteDay Antibacterial Wet Towels by

Drug Labeling and Warnings

WhiteDay Antibacterial Wet Towels by is a Otc medication manufactured, distributed, or labeled by AKGUN COCUK BEZI VE KOZMETIK URUNLERI SANAYI TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WHITEDAY ANTIBACTERIAL WET TOWELS- benzalkonium chloride cloth 
AKGUN COCUK BEZI VE KOZMETIK URUNLERI SANAYI TICARET LIMITED 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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WhiteDay Antibacterial Wet Towels

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 (0.45%, volume/volume (w/v)) in an aqueous solution.
  2. Glycerol (0.8% w/v).
  3. Phenoxyethanol (0.1% w/v).
  4. Cocamidopropyl Betaine (0.4% w/v).
  5. Polysorbate 20 (0.2% w/v).
  6. Peg-7 Glyceryl Cocoate (0.3% w/v).
  7. Citric Acid (0.1% w/v).
  8. 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)

Benzalkonium Chloride 0.45% w/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer 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 this product keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 wipes 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

Citric acid, Cocoamidopropyl betaine, glycerin, Phenoxyethanol, Polysorbate 20, Peg-7 glyceryl cocoate, purified water USP

Package Label - Principal Display Panel

72 pcs NDC: 86812-002-01 72 pcs

WHITEDAY ANTIBACTERIAL WET TOWELS 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 86812-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.45 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.8 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.1 g  in 100 mL
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.2 g  in 100 mL
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) 0.3 g  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.1 g  in 100 mL
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 0.4 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 86812-002-0172 mL in 1 PACKAGE; Type 0: Not a Combination Product03/30/202010/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202010/30/2020
Labeler - AKGUN COCUK BEZI VE KOZMETIK URUNLERI SANAYI TICARET LIMITED SIRKETI (355120101)
Registrant - AKGUN COCUK BEZI VE KOZMETIK URUNLERI SANAYI TICARET LIMITED SIRKETI (355120101)
Establishment
NameAddressID/FEIBusiness Operations
AKGUN COCUK BEZI VE KOZMETIK URUNLERI SANAYI TICARET LIMITED SIRKETI355120101manufacture(86812-002)

Revised: 10/2020
 
AKGUN COCUK BEZI VE KOZMETIK

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