SPL v5
SPL
SPL Set ID 9e87277c-d4e8-41f2-9ca7-9c7abc97e0b1
Route
TOPICAL
Published
Effective Date 2015-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Water Sodium Lauryl Sulfate 2-bromo-2-nitroethanol 2-methyl-2-propylpropane-1,3-diol Aloe Arborescens Leaf Disodium Edta-copper Triethanolamine Benzoate Glycerin Tocopheryl Retinoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-04-15
Description

Benzalkonium chloride  0.1%

Purpose

antibacterial

Medication Information

Purpose

antibacterial

Description

Benzalkonium chloride  0.1%

Use

decreases bacteria on skin

Section 51727-6

water ,sodium lauryl sulfate,fragrance,2-bromo-2-nitropropane-1,3-diol,aloe barbadensis leaf extract,disodium EDTA,triethanolamine,glycerin,tocopheryl acetate.

Section 51945-4

Warnings

for external use only

over large areas of the body 

if you are allergic to ay of the ingredients

When using this product avoid contact with eyes and face.

if contact occurs,flush throughly with water



stop use and ask a doctor uf irritation or rash develops and continues for more than 72 hours.

Directions

for adults and children of 2 years and over.

children under 2 years ask a doctor before use

allow to dry without wiping

Active Ingredient

Benzalkonium chloride  0.1%

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.

Structured Label Content

Use

decreases bacteria on skin

Section 51727-6 (51727-6)

water ,sodium lauryl sulfate,fragrance,2-bromo-2-nitropropane-1,3-diol,aloe barbadensis leaf extract,disodium EDTA,triethanolamine,glycerin,tocopheryl acetate.

Section 51945-4 (51945-4)

Purpose

antibacterial

Warnings

for external use only

over large areas of the body 

if you are allergic to ay of the ingredients

When using this product avoid contact with eyes and face.

if contact occurs,flush throughly with water



stop use and ask a doctor uf irritation or rash develops and continues for more than 72 hours.

Directions

for adults and children of 2 years and over.

children under 2 years ask a doctor before use

allow to dry without wiping

Active Ingredient (Active ingredient)

Benzalkonium chloride  0.1%

Keep Out of Reach of Children (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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:56.193053 · Updated: 2026-03-14T22:53:59.906934