antibacterial wipes

antibacterial wipes
SPL v2
SPL
SPL Set ID b41a4e86-38ec-4e6b-e053-2a95a90aabe8
Route
topical
Published
Effective Date 2020-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
aloe vera leaf .alpha.-tocopherol propylene glycol n-alkyl ethylbenzyl dimethyl ammonium chloride (c12-c14) decyl glucoside water edetate disodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-11-15

Purpose

Antimicrobial Agent

Description

Drug Facts


Medication Information

Warnings

For external use only.

Purpose

Antimicrobial Agent

Directions

Tear open the packet and remove wipe.

Wet hands thoroughly with product and let hands air dry.

Throw used wipe in trash.

Do not flush.

Other Information

Adults and children 2 years and over. Apply to hands. Allow skin to dry without Wiping.

Children under 2 years. Consult a doctor prior to use.

Inactive Ingredients

C12-14 Alkyl Dimethyl, Ethylbenzyl Ammonium Chloride, Alkyl Polyglucoside, Disodium EDTA, Propylene Glycol, Vitamin E, Aloe Barbadensis Leaf Juice, Aqua.

Description

Drug Facts

Use

Decreases bacteria on skin.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Discontinue use and contact a doctor if irritation and redness develop and condition persists for more than 72 hours.

Section 50567-7

When using this product, avoid contact with eyes and mouth. lf product gets in the eyes, flush thoroughly with water.

Do Not Use

Do not use if you are allergic to any of the ingredients.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Antibacterial Wipes Package Label

NDC:81079-001-01

NDC:81079-001-02

​NDC:81079-001-03

​NDC:81079-001-04

​NDC:81079-001-05

​NDC:81079-001-06


Structured Label Content

Warnings

For external use only.

Purpose

Antimicrobial Agent

Directions

Tear open the packet and remove wipe.

Wet hands thoroughly with product and let hands air dry.

Throw used wipe in trash.

Do not flush.

Other Information (Other information)

Adults and children 2 years and over. Apply to hands. Allow skin to dry without Wiping.

Children under 2 years. Consult a doctor prior to use.

Inactive Ingredients (Inactive ingredients)

C12-14 Alkyl Dimethyl, Ethylbenzyl Ammonium Chloride, Alkyl Polyglucoside, Disodium EDTA, Propylene Glycol, Vitamin E, Aloe Barbadensis Leaf Juice, Aqua.

Use

Decreases bacteria on skin.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Discontinue use and contact a doctor if irritation and redness develop and condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes and mouth. lf product gets in the eyes, flush thoroughly with water.

Do Not Use (Do not use)

Do not use if you are allergic to any of the ingredients.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Antibacterial Wipes Package Label

NDC:81079-001-01

NDC:81079-001-02

​NDC:81079-001-03

​NDC:81079-001-04

​NDC:81079-001-05

​NDC:81079-001-06


Advanced Ingredient Data


Raw Label Data

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