Product listing of human OTC wet wipes

SELPAK ANTIBACTERIAL WET WIPES by

Drug Labeling and Warnings

SELPAK ANTIBACTERIAL WET WIPES by is a Otc medication manufactured, distributed, or labeled by ECZACIBASI TUKETIM URUNLERI SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SELPAK ANTIBACTERIAL WET WIPES- chlorhexidine digluconate cloth 
ECZACIBASI TUKETIM URUNLERI SANAYI VE TICARET ANONIM 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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Product listing of human OTC 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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. 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)

Alcohol 80% v/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. Flammable. Keep away from heat or flame

Do not use

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

When using this product keep out of eyes, ears, and mouth. 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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Product package label

NDC: 80877-001-01 10 wipes in 1 pack, 3 pack in 1 bag

NDC: 80877-001-03 10 wipes in 1 pack, 10 pack in 1 bag

SELPAK ANTIBACTERIAL WET WIPES 
chlorhexidine digluconate cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80877-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	0.35 U  in 100 U

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.1 U  in 100 U
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)	0.2 U  in 100 U
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.08 U  in 100 U
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)	0.15 U  in 100 U
WATER (UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	0.7 U  in 100 U
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.72 U  in 100 U
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.033 U  in 100 U

Product Characteristics
Color		Score
Shape	RECTANGLE (Product package is a rectangular packet containing multiple disinfectant wipes. There are two pack sizes, one is bundle of 3 packets in 1 bag and each packet has 10 wipes and other is bundle of 10 packets in 1 bag and each packet has 10 wipes)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80877-001-03	100 U in 1 BAG; Type 0: Not a Combination Product	11/14/2020	12/01/2022
2	NDC: 80877-001-01	30 U in 1 BAG; Type 0: Not a Combination Product	11/14/2020	12/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part349	11/14/2020	12/01/2022

Labeler - ECZACIBASI TUKETIM URUNLERI SANAYI VE TICARET ANONIM SIRKETI (643281470)

Establishment
Name	Address	ID/FEI	Business Operations
ECZACIBASI TUKETIM URUNLERI SANAYI VE TICARET ANONIM SIRKETI		643281470	manufacture(80877-001)

Revised: 12/2022

Document Id: eebfdde2-d770-80b6-e053-2995a90ae218

34390-5

Set id: b2548a77-36d6-564f-e053-2995a90adc58

Version: 2

Effective Time: 20221201

 

ECZACIBASI TUKETIM U