PRISTINE MK 70% ALCOHOL WET WIPES ANTIBACTERIAL ANTISEPTIC WET WIPES

70% ALCOHOL WET WIPES by

Drug Labeling and Warnings

70% ALCOHOL WET WIPES by is a Otc medication manufactured, distributed, or labeled by PRISTINE MK LLC, FRESH CO COSMETICS SH.P,K, FRESH CO COSMETICS SH.P.K. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

70% ALCOHOL WET WIPES- isopropyl alcohol cloth 
PRISTINE MK LLC

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PRISTINE MK 70% ALCOHOL WET WIPES ANTIBACTERIAL ANTISEPTIC WET WIPES

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antibacterial Antiseptic Wet Wipes

Use

Sanitizes and decreases bacteria on skin

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 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 at 1-800-222-1222

Directions for use

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

- to dispense peel back front label slowly remove wipes

- to reseal pouch firmly run thumb over the label

- dont flush

Other information

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

Inactive ingredients

water, glycerine, tocopheryl acetate ( vitamin E) panthenol

Package Label - Principal Display Panel

48 pcs Wipes NDC: 81214-260-48

70% ALCOHOL WET WIPES 
isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81214-260
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.01 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.8 mL  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z)	0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	29.18 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81214-260-48	260 mL in 1 POUCH; Type 0: Not a Combination Product	11/01/2020

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 - PRISTINE MK LLC (117674251)

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

Establishment
Name	Address	ID/FEI	Business Operations
FRESH CO COSMETICS SH.P.K		499428868	manufacture(81214-260)

Revised: 4/2025

Document Id: 3360b6a1-e40e-b71e-e063-6394a90a3e45

34390-5

Set id: b5b5a883-949c-eeb1-e053-2995a90a11c4

Version: 3

Effective Time: 20250422