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

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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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

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

Inactive ingredients

water, glycerine, tocopheryl acetate ( vitamin E) panthenol

Package Label - Principal Display Panel

wipes48 pcs Wipes NDC: 81214-260-48

70% ALCOHOL WET WIPES 
isopropyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81214-260
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81214-260-48260 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/01/2020
Labeler - PRISTINE MK LLC (117674251)
Registrant - FRESH CO COSMETICS SH.P,K (499428868)
Establishment
NameAddressID/FEIBusiness Operations
FRESH CO COSMETICS SH.P.K499428868manufacture(81214-260)

Revised: 12/2020
Document Id: b66c0233-4d9f-15e3-e053-2a95a90af700
Set id: b5b5a883-949c-eeb1-e053-2995a90a11c4
Version: 2
Effective Time: 20201214
 
PRISTINE MK LLC