70%ALCOHOL WET WIPES- antibacterial antiseptic wet wipes cloth

70%ALCOHOL WET WIPES by

Drug Labeling and Warnings

70%ALCOHOL 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]

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

70% ALCOHOL WET WIPES

Antibacterial ANTISEPTIC WET WIPES

trusted protection

Use

Sanitize 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

keep out of eyes, ears, and mouth, In case of contact with eyes, rinse eyes thoroughly with water

Stop use and ask a doctor

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.1-800-222-1222

adults and childrens 2 years & 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
• dont flush

Other information

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

Inactive ingredients

Water, glycerin,tocopheryl acetate ( vitamin E), Panthenol

Package Label - Principal Display Panel

NDC: 80638-260-48

INGREDIENTS AND APPEARANCE

70%ALCOHOL WET WIPES 
antibacterial antiseptic wet wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80638-260
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
GLYCERIN (UNII: PDC6A3C0OX)	0.8 mL  in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	29.18 mL  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z)	0.01 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80638-260-48	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	M003	11/01/2020

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(80638-260)