ANTIBACTERIAL ANTISEPTIC WET WIPES- benzalkonium chloride cloth

Antibacterial Antiseptic Wet Wipes by

Drug Labeling and Warnings

Antibacterial Antiseptic 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)

Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Antibacterial Wet Wipes

Use

Decrease bacteria on skin. For use when soap and water are not available.

Warnings

For external use only.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product do not get into eyes, ears, and mouth. If contact occurs,rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and continues for morethan 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 ordevelops and continues for morethan 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 1800-222-1222.

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.
• donot flush

Other information

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

Inactive ingredients

deionised water, ceteary isononanoate,cetearyl alcohol, glyceryl stearate, glycerin, ceteareth-12, cetyl palmitate, phenoxyethanol, sodium benzoate, fragrance, citric acid, disodium EDTA

Package Label - Principal Display Panel

48 wet wipes NDC: 80638-150-48

102 wet wipes NDC: 80638-150-12

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL ANTISEPTIC WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80638-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETEARYL ISONONANOATE (UNII: P5O01U99NI)	0.08 mL  in 100 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	0.08 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)	0.08 mL  in 100 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.08 mL  in 100 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	0.08 mL  in 100 mL
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.08 mL  in 100 mL
CETYL PALMITATE (UNII: 5ZA2S6B08X)	0.3 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.08 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.08 mL  in 100 mL
CETEARETH-12 (UNII: 7V4MR24V5P)	0.3 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.3 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80638-150-48	290 mL in 1 POUCH; Type 0: Not a Combination Product	09/18/2020
2	NDC: 80638-150-12	590 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(80638-150)