ANTIBACTERIAL ANTISEPTIC WET WIPES 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]

ANTIBACTERIAL ANTISEPTIC WIPES 120 PCS

ANTIBACTERIAL ANTISEPTIC WET WIPES TRUSTED PROTECTION

Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.13 % v/v. Purpose: Antiseptic

Purpose

ANTIBACTERIAL ANTISEPTIC WET WIPES

Use

DECREASES BACTERIA ON SKIN FOR USE WHEN SOAP AND WATER 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 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.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

do not flush

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C

Inactive ingredients

deoinised water, cetearyl isononanoate, ceteareth-20, cetearyl alcohol, glyceryl stearate,glycerine, ceteareth-12, cetyl palmitate, phenoxyethanol,sodium benzoate, fragrance, citric acid, disodium EDTA

Package Label - Principal Display Panel

600 mL NDC: 80638-600-01

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL ANTISEPTIC WET WIPES 
antibacterial antiseptic wet wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80638-600
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
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.03 mL  in 100 mL
CETEARYL ISONONANOATE (UNII: P5O01U99NI)	0.03 mL  in 100 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.03 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.1 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.03 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	99.52 mL  in 100 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	0.03 mL  in 100 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	0.01 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.03 mL  in 100 mL
CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)	0.01 mL  in 100 mL
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)	0.01 mL  in 100 mL
CETEARETH-12 (UNII: 7V4MR24V5P)	0.01 mL  in 100 mL
CETYL PALMITATE (UNII: 5ZA2S6B08X)	0.01 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80638-600-01	600 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(80638-600)