Antibacterial Soap

Antibacterial Soap
SPL v3
SPL
SPL Set ID 76a5671c-d501-a8e2-e053-2991aa0a1cff
Route
TOPICAL
Published
Effective Date 2018-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Sodium Palm Kernelate Sodium Palmitate Water Glycerin Sodium Chloride Edetate Sodium Fd&c Yellow No. 5 Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-09-21

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

for washing to decrease bacteria on the skin

Warnings

For external use only

Directions

■ wet bar with water ■ lather vigorously and wash skin ■ rinse and dry thoroughly

Package Label

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

sodium palm kernelate, sodium palmate, water, fragrance, glycerin, sodium chloride, tetrasodium EDTA, FD&C yellow no. 5, FD&C red no. 4

When Using This Product

avoid contact with eyes. In case of eye contact, flush with water

Stop Use and Ask A Doctor If

■ irritation and redness develops

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

for washing to decrease bacteria on the skin

Purpose

Antibacterial

Warnings

For external use only

Directions

■ wet bar with water ■ lather vigorously and wash skin ■ rinse and dry thoroughly

Package Label

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

sodium palm kernelate, sodium palmate, water, fragrance, glycerin, sodium chloride, tetrasodium EDTA, FD&C yellow no. 5, FD&C red no. 4

When Using This Product (When using this product)

avoid contact with eyes. In case of eye contact, flush with water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ irritation and redness develops

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

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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