FRESCOSAL ALCOHOL WIPES- 70% isopropyl alcohol cloth

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]

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

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

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

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

INGREDIENTS AND APPEARANCE

FRESCOSAL ALCOHOL WIPES 
70% isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80638-151
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
GLYCERIN (UNII: PDC6A3C0OX)	0.8 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	28.2 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80638-151-70	250 mL in 1 POUCH; Type 0: Not a Combination Product	09/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/18/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
FRESH CO COSMETICS SH.P.K.		499428868	manufacture(80638-151)