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 PRISTINE MK LLC, 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, Wet Wipes

Use

decreases 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

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

Other information

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

Inactive ingredients

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

Package Label - Principal Display Panel

120 WIPES NDC: 81214-600-01

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL ANTISEPTIC WET WIPES 
antibacterial antiseptic wet wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81214-600
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
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	0.03 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
EDETATE DISODIUM (UNII: 7FLD91C86K)	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
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.03 mL  in 100 mL
CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)	0.01 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.1 mL  in 100 mL
CETEARYL ISONONANOATE (UNII: P5O01U99NI)	0.03 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	99.52 mL  in 100 mL
CETYL PALMITATE (UNII: 5ZA2S6B08X)	0.01 mL  in 100 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.03 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81214-600-01	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 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(81214-600)