78048-015

78048-015
SPL v1
SPL
SPL Set ID aeb1d32f-35de-686b-e053-2a95a90ad7d6
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Diazolidinyl Urea Guaraprolose (1300 Mpa.s At 1%) Water Sodium Borate Propylene Glycol Silver Nitrate Phenoxyethanol Iodopropynyl Butylcarbamate Pentasodium Pentetate D&c Red No. 28

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

benzalkonium chloride 0.1%

Purpose

Anti-septic


Medication Information

Purpose

Anti-septic

Description

benzalkonium chloride 0.1%

Use

Anti-bacterial slime helps reduce bateria that potentially can cause disease.

For use when soap and water are not available.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs.

If swallowed, get medical help.

Section 50567-7

Keep out of eyes, ears, and mouth.

in case of contact with eyes, rinse eyes thoroughly with water.

Warnings

For external use only.

Keep appropriately in container after use.

Directions

place enough on hands and rub hands together not less than 1- 2 minutes.hands dry.

Supervise children under 3 years of age when using this product to avoid swallowing.

anti-bacterial slime can be used over and over and best within 1 months if keep appropriately in container whenever after use.

Do Not Use

in children less than 3.

on open skin wounds.

Other Information

store in room temperature ( 25 C/77 F )

avoid freezing and excessive heat above 70 C ( 158 F )

Active Ingredient(s)

benzalkonium chloride 0.1%

Inactive Ingredients

water, Propylene glycol, Hydroxypropyl Guar, Phenoxyethanol, Sodium Borate, Diazolidinyl Urea,

pentasodium pentetate, silver nitrate, Iodopropynyl Butylcarbamate, red 28

Package Label Principal Display Panel


Structured Label Content

Use

Anti-bacterial slime helps reduce bateria that potentially can cause disease.

For use when soap and water are not available.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs.

If swallowed, get medical help.

Section 50567-7 (50567-7)

Keep out of eyes, ears, and mouth.

in case of contact with eyes, rinse eyes thoroughly with water.

Purpose

Anti-septic

Warnings

For external use only.

Keep appropriately in container after use.

Directions

place enough on hands and rub hands together not less than 1- 2 minutes.hands dry.

Supervise children under 3 years of age when using this product to avoid swallowing.

anti-bacterial slime can be used over and over and best within 1 months if keep appropriately in container whenever after use.

Do Not Use (Do not use)

in children less than 3.

on open skin wounds.

Other Information (Other information)

store in room temperature ( 25 C/77 F )

avoid freezing and excessive heat above 70 C ( 158 F )

Active Ingredient(s)

benzalkonium chloride 0.1%

Inactive Ingredients (Inactive ingredients)

water, Propylene glycol, Hydroxypropyl Guar, Phenoxyethanol, Sodium Borate, Diazolidinyl Urea,

pentasodium pentetate, silver nitrate, Iodopropynyl Butylcarbamate, red 28

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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