78583-701

78583-701
SPL v4
SPL
SPL Set ID e309c797-8009-82ae-e053-2a95a90a4ffd
Route
TOPICAL
Published
Effective Date 2021-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Glycerin Orange Oil Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-06-04

Description

BENZALKONIUM CHLORIDE 0.1%

Purpose

ANTIMICROBIAL


Medication Information

Purpose

ANTIMICROBIAL

Description

BENZALKONIUM CHLORIDE 0.1%

Use

peel back front label slowy.

use caution near electric appliances to avoid electric shock

Warnings

for external sue only.

sotre away from direct sunlight or high temperature.

use caution near electric appliances to avoid electric shock.

Direction

To dispense, peel back front label at tab

Remove towelettes as needed

Reseal pouch by pressing label firmly back into place

Do Not Use

do not flush

do not use if you are allergic to any of the ingredients

Ask A Doctor

f swallowed, get medical help or contact a Poison control center right away

Package Label

Active Ingredient

BENZALKONIUM CHLORIDE 0.1%

Other Information

7.9 in x 5.9 in (20cm x15cm )

Inactive Ingredieint

Aqua

Glycerine

Orange Sweet Ext.

Stop Use and Ask A Doctor.

stop use and ask a doctor if irritationor or rash edvelopes and continues for more than 72 hours.

Keep Out of Reach of Children.

Keep out of reach of children.


Structured Label Content

Use

peel back front label slowy.

use caution near electric appliances to avoid electric shock

Purpose (PURPOSE)

ANTIMICROBIAL

Warnings

for external sue only.

sotre away from direct sunlight or high temperature.

use caution near electric appliances to avoid electric shock.

Direction

To dispense, peel back front label at tab

Remove towelettes as needed

Reseal pouch by pressing label firmly back into place

Do Not Use (Do not use)

do not flush

do not use if you are allergic to any of the ingredients

Ask A Doctor (ask a doctor)

f swallowed, get medical help or contact a Poison control center right away

Package Label

Active Ingredient (ACTIVE INGREDIENT)

BENZALKONIUM CHLORIDE 0.1%

Other Information (Other information)

7.9 in x 5.9 in (20cm x15cm )

Inactive Ingredieint (INACTIVE INGREDIEINT)

Aqua

Glycerine

Orange Sweet Ext.

Stop Use and Ask A Doctor. (stop use and ask a doctor.)

stop use and ask a doctor if irritationor or rash edvelopes and continues for more than 72 hours.

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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