PRISTINE MK Antibacterial antiseptic WET WIPES

ANTIBACTERIAL ANTISEPTIC WET WIPES by

Drug Labeling and Warnings

ANTIBACTERIAL ANTISEPTIC WET WIPES by is a Otc medication manufactured, distributed, or labeled by FRESH CO COSMETICS SH. P.K.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL ANTISEPTIC WET WIPES- antibacterial antiseptic wet wipes cloth 
FRESH CO COSMETICS SH. P.K.

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PRISTINE MK Antibacterial antiseptic WET WIPES

ANTIBACTERIAL ANTISEPTIC WIPES 120 PCS

ANTIBACTERIAL ANTISEPTIC WET WIPES TRUSTED PROTECTION

Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.13 % v/v. Purpose: Antiseptic

Purpose

ANTIBACTERIAL ANTISEPTIC WET WIPES

Use

DECREASES BACTERIA ON SKIN FOR USE WHEN SOAP AND WATER 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 do not get into eyes, ears and mouth if contact occurs rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours. 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.1-800-222-1222

Directions

adults and children 2 years and over - apply to hands , wet hands thoroughly with product and allow it to dry

children under 2 years - ask a doctor before use

Directions for use

to dispense peel back front label slowly remove wipes

to reseal pouch firmly run thumb over the label

do not flush

Other information

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

Inactive ingredients

deoinised water, cetearyl isononanoate, ceteareth-20, cetearyl alcohol, glyceryl stearate,glycerine, ceteareth-12, cetyl palmitate, phenoxyethanol,sodium benzoate, fragrance, citric acid, disodium EDTA

Package Label - Principal Display Panel

600 mL NDC: 80638-600-01

ANTIBACTERIAL ANTISEPTIC WET WIPES 
antibacterial antiseptic wet wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80638-600
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.03 mL  in 100 mL
CETEARYL ISONONANOATE (UNII: P5O01U99NI)	0.03 mL  in 100 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.03 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.1 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.03 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	99.52 mL  in 100 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	0.03 mL  in 100 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	0.01 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.03 mL  in 100 mL
CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)	0.01 mL  in 100 mL
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)	0.01 mL  in 100 mL
CETEARETH-12 (UNII: 7V4MR24V5P)	0.01 mL  in 100 mL
CETYL PALMITATE (UNII: 5ZA2S6B08X)	0.01 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80638-600-01	600 mL in 1 POUCH; Type 0: Not a Combination Product	11/01/2020	12/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/01/2020	12/31/2024

Labeler - FRESH CO COSMETICS SH. P.K. (499428868)

Registrant - FRESH CO COSMETICS SH. P.K. (499428868)

Establishment
Name	Address	ID/FEI	Business Operations
FRESH CO COSMETICS SH. P.K.		499428868	manufacture(80638-600)

Revised: 4/2025

Document Id: 334c320a-00c0-a48d-e063-6294a90a1967

34390-5

Set id: b555c191-7037-68f2-e053-2995a90a6351

Version: 6

Effective Time: 20250421