IVRESSE ANTIBACTERIAL WET WIPE- benzalkonium chloride cloth

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
BLUE ICEBERG LABS LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Authorization status:
OTC monograph not final
Authorization number:
81255-001-72

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IVRESSE ANTIBACTERIAL WET WIPE- benzalkonium chloride cloth

BLUE ICEBERG LABS LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ivresse Antibacterial Wet Wipe

Drug Facts

Active Ingredient

Benzalkonium chloride 0.13% w/v

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. 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 this product

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

Stop use and ask a doctor

If irritation or rash occurs. 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.

Directions

place enough product to cover all surfaces. Rub hands together until dry. supervise children under 6

years of age when using this product to avoid swallowing

Other Information

store between 88-77ºF (20-25ºC)

may discolor certain fabrics and wood surfaces.

TAMPER EVIDENT Do not use if the sealable tab is open or torn.

Inactive ingredients

Water, Benzyl Alcohol, Phenoxyethanol, Propylene glycol, Cocobetaine, Aloe Barbadensis Leaf

Juice, Glycerin, Fragrance, Disodium EDTA, PEG-40 Caster Oil.

Package Labeling:

IVRESSE ANTIBACTERIAL WET WIPE

benzalkonium chloride cloth

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 1255-0 0 1

BLUE ICEBERG LABS LLC

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

1.3 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

CO CO -BETAINE (UNII: 0 3DH2IZ3FY)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

GLYCERIN (UNII: PDC6 A3C0 OX)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

PEG-4 0 CASTO R O IL (UNII: 4ERD20 76 EF)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:8 1255-

0 0 1-72

1 in 1 PACKET

12/16 /20 20

1

2 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System

(syringe, patch, etc.)

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

12/16 /20 20

Labeler -

BLUE ICEBERG LABS LLC (117620189)

Revised: 12/2020

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