SPL v1
SPL
SPL Set ID 526c09e0-dfd4-4284-938f-beaea7c9d22c
Route
TOPICAL
Published
Effective Date 2012-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzethonium (0.2 g)
Inactive Ingredients
Water Aloe Aloe Vera Leaf Glycerin Propylene Glycol Polyoxyl 40 Hydrogenated Castor Oil Iodopropynyl Butylcarbamate Edetate Disodium .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-12-06

Description

Active Ingredient Benzethonium Chloride 0.2%


Medication Information

Warnings and Precautions
WARNING:

For external use only.Not use around/in the eyes. In case of contact, flush thoroughly with water.
Indications and Usage
Keep your hands clean and germ-free everywhere you go!
Dosage and Administration
DIRECTIONS:

Use wet wipe to clean hand without soap or water.



Description

Active Ingredient Benzethonium Chloride 0.2%

Section 50565-1
Keep out of reach of children.

Section 50566-9
Stop use and ask a doctor if irritation and redness develop.

Section 51727-6

Inactive Ingredient

Water, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Iodopropynyl Butylcarbamate, Fragrance, Disodium EDTA, Vitamin E

Section 51945-4
Section 55105-1
Purpose

Antimicrobial
Section 55106-9
Active Ingredient

Benzethonium Chloride 0.2%




Structured Label Content

Indications and Usage (34067-9)
Keep your hands clean and germ-free everywhere you go!
Dosage and Administration (34068-7)
DIRECTIONS:

Use wet wipe to clean hand without soap or water.



Warnings and Precautions (34071-1)
WARNING:

For external use only.Not use around/in the eyes. In case of contact, flush thoroughly with water.
Section 50565-1 (50565-1)
Keep out of reach of children.

Section 50566-9 (50566-9)
Stop use and ask a doctor if irritation and redness develop.

Section 51727-6 (51727-6)

Inactive Ingredient

Water, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice, PEG-40 Hydrogenated Castor Oil, Iodopropynyl Butylcarbamate, Fragrance, Disodium EDTA, Vitamin E

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose

Antimicrobial
Section 55106-9 (55106-9)
Active Ingredient

Benzethonium Chloride 0.2%




Advanced Ingredient Data


Raw Label Data

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