Drug Facts Box (back Label)

Drug Facts Box (back Label)
SPL v1
SPL
SPL Set ID 4059dafb-7790-4f99-bc73-715c6363c6b7
Route
TOPICAL
Published
Effective Date 2010-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1000 mL)
Inactive Ingredients
Water Polysorbate 20 Octinoxate Avobenzone Octisalate Propylene Oxide Polyoxyl 40 Hydrogenated Castor Oil Aloe Vera Leaf Edetate Sodium Dmdm Hydantoin Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-11-16
Description

BENZALKONIUM CHLORIDE  0.1% 

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

BENZALKONIUM CHLORIDE  0.1% 

Uses

To help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

For external use only.

Directions

Pump enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Active Ingredient

BENZALKONIUM CHLORIDE  0.1% 

Inactive Ingredients

Water, Polysorbate 20, Ethylhexyl Methoxycinnamate, Ethylhexyl Sallicylate, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Fragrance, Tetrasodium EDTA, DMDM Hydantoin, Sodium Hydroxide, Blue 1, Yellow 5

When Using This Product

avoid contact with eyes. If contact occurs, rinse with water.

Stop Using and Ask A Doctor

if irritation or rash develops and lasts

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Package Front and Back Labels

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Structured Label Content

Uses

To help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Purpose

Antimicrobial

Warnings

For external use only.

Directions

Pump enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Active Ingredient (ACTIVE INGREDIENT)

BENZALKONIUM CHLORIDE  0.1% 

Inactive Ingredients

Water, Polysorbate 20, Ethylhexyl Methoxycinnamate, Ethylhexyl Sallicylate, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Fragrance, Tetrasodium EDTA, DMDM Hydantoin, Sodium Hydroxide, Blue 1, Yellow 5

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse with water.

Stop Using and Ask A Doctor (Stop using and ask a doctor)

if irritation or rash develops and lasts

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

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Package Front and Back Labels

ht.jpg

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:09.452568 · Updated: 2026-03-14T22:52:30.292621