FRECOSAL 70% ALCOHOL WIPES

Frescosal Alcohol Wipes by

Drug Labeling and Warnings

Frescosal Alcohol 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]

FRESCOSAL ALCOHOL WIPES- 70% isopropyl alcohol cloth 
FRESH CO COSMETICS SH.P.K.

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FRECOSAL 70% ALCOHOL WIPES

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Sanitizes and decreases bacteria on skin.

Warnings

For external use only. Flammable. Keep away from fire 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.

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

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
  • don't flush

Other information

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

Inactive ingredients

water, glycerin

Package Label - Principal Display Panel

NDC: 80638-151-70

48 wipes

FRESCOSAL ALCOHOL WIPES 
70% isopropyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80638-151
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
GLYCERIN (UNII: PDC6A3C0OX) 0.8 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.2 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80638-151-70250 mL in 1 POUCH; Type 0: Not a Combination Product09/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00309/18/202001/01/2025
Labeler - FRESH CO COSMETICS SH.P.K. (499428868)
Establishment
NameAddressID/FEIBusiness Operations
FRESH CO COSMETICS SH.P.K.499428868manufacture(80638-151)

Revised: 1/2025
Document Id: 2c722322-42e5-7678-e063-6294a90a0e93
Set id: b01451a4-339c-3a79-e053-2a95a90a16c9
Version: 4
Effective Time: 20250124