Ultraclean Antibacterial Wet Wipes

Ultraclean Antibacterial Wet Wipes by

Drug Labeling and Warnings

Ultraclean Antibacterial Wet Wipes 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]

ULTRACLEAN ANTIBACTERIAL WET WIPES- 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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Ultraclean Antibacterial Wet Wipes

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

ULTRACLEAN ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86812-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
LIME OIL (UNII: UZH29XGA8G)	0.2 g  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86812-004-01	72 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/30/2020	10/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/30/2020	10/30/2020

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
Name	Address	ID/FEI	Business Operations
AKGUN COCUK BEZI VE KOZMETIK URUNLERI SANAYI TICARET LIMITED SIRKETI		355120101	manufacture(86812-004)

Revised: 10/2020

Document Id: b2c2da9a-93b3-d250-e053-2995a90a8d75

34390-5

Set id: a8fb9258-1aed-164c-e053-2995a90a7953

Version: 5

Effective Time: 20201028

 

AKGUN COCUK BEZI VE KOZMETIK