70% ALCOHOL WET WIPES- isopropyl alcohol cloth

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]

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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 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

INGREDIENTS AND APPEARANCE

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 not final	part333A	11/01/2020

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)