Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID eae72d60-b1fc-4bf1-b6b4-9d447e1a4fd2
Route
TOPICAL
Published
Effective Date 2020-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Methylchloroisothiazolinone Methylisothiazolinone Citric Acid Monohydrate Sodium Chloride Water Sodium Laureth Sulfate Cocamidopropyl Betaine Coco Diethanolamide Fd&c Red No. 40 Fd&c Blue No. 1 Limonene, (+)- D&c Red No. 33 Glycerin Sulisobenzone Lauryl Glucoside Fd&c Yellow No. 5 Benzyl Alcohol Edetate Disodium Anhydrous Magnesium Citrate Propylene Glycol Linalool, (+/-)- Fd&c Yellow No. 6 Benzyl Benzoate Benzyl Salicylate .alpha.-hexylcinnamaldehyde Magnesium Nitrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-23
Description

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13% w/w

Use

for washing hands to decrease bacteria on skin.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or go to Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness develops.

Section 50567-7

When using this product avoid contact with eyes, in case of eye contact, flush with water.

Warnings

For external use only

Directions

Pump onto wet hands, vigorously work into a lather and rinse thoroughly.

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Other Information

Store in a cool dry place below 104 °F.

Inactive Ingredients

water, cocamidopropyl betaine, sodium laureth sulfate, cocamide DEA, lauryl glucoside, glycerin, fragrance, citric acid, benzophenone-4, propylene glycol, sodium chloride, benzyl alcohol, magnesium nitrate, methyIchloroisothiazolinone, methylisothiazolinone, red 33, blue 1

Principal Display Panel 400 Ml Label

HOBBY®

Antibacterial

 Liquid Hand Soap

BERRY MEDLEY

13.5 FL OZ

(400 ml)

Structured Label Content

Use

for washing hands to decrease bacteria on skin.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or go to Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develops.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes, in case of eye contact, flush with water.

Purpose

Antibacterial

Warnings

For external use only

Directions

Pump onto wet hands, vigorously work into a lather and rinse thoroughly.

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13% w/w

Other Information (Other information)

Store in a cool dry place below 104 °F.

Inactive Ingredients (Inactive ingredients)

water, cocamidopropyl betaine, sodium laureth sulfate, cocamide DEA, lauryl glucoside, glycerin, fragrance, citric acid, benzophenone-4, propylene glycol, sodium chloride, benzyl alcohol, magnesium nitrate, methyIchloroisothiazolinone, methylisothiazolinone, red 33, blue 1

Principal Display Panel 400 Ml Label (Principal Display Panel - 400 mL Label)

HOBBY®

Antibacterial

 Liquid Hand Soap

BERRY MEDLEY

13.5 FL OZ

(400 ml)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:58.622231 · Updated: 2026-03-14T22:58:47.860892