66949-393 / 3339 Pear Ab

66949-393 / 3339 Pear Ab
SPL v9
SPL
SPL Set ID 5bc1cc32-5d18-00a8-e053-2991aa0a0c81
Route
TOPICAL
Published
Effective Date 2017-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Methylisothiazolinone Fd&c Yellow No. 5 Methylchloroisothiazolinone Peg-120 Methyl Glucose Dioleate Anhydrous Citric Acid Coco Diisopropanolamide Water Cetrimonium Chloride Lauroyl/myristoyl Amidopropyl Amine Oxide Glycerin Sodium Chloride Edetic Acid Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-03
Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic Handwash

Medication Information

Purpose

Antiseptic Handwash

Description

Benzalkonium Chloride 0.13%

Uses

For hand washing to decrease bacteria on skin.

Section 51945-4

Warnings

For external use only.

Do not use in the eyes; if in eyes, rinse promptly and thoroughly with water.

Directions
  • Wet hands with water.
  • Press pump to dispense product into hands.
  • Massage soap into hands and wrists, emphasizing back of hands, knuckles and cuticles.
  • Rinse hands thoroughly and dry.
Active Ingredient

Benzalkonium Chloride 0.13%

Other Information
  • Store at 20 to 25°C (68 to 77°F).
  • Do not freeze.
  • Dispose in accordance with all applicable federal, state and local regulations.
Inactive Ingredients

Water, Cetrimonium Chloride, Lauryl/Myristyl Amidopropyl Amine Oxide, Glycerin, Cocamide DIPA, PEG-120 Methyl Glucose Dioleate, Sodium Chloride, Fragrance, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Red 4, Yellow 5

Questions Or Comments?

Call 1-877-I-BUY-ZEP (1-877-428-9937)

Stop Use and Ask Doctor

Stop use and ask doctor if skin irritation or redness persists for more than 72 hours.

When Using This Product
  • Do not swallow.
  • If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.
Keep Out of Reach of Children and Pets

Keep out of reach of children and pets. Children must be supervised in use of this product.

Structured Label Content

Uses

For hand washing to decrease bacteria on skin.

Section 51945-4 (51945-4)

Purpose

Antiseptic Handwash

Warnings

For external use only.

Do not use in the eyes; if in eyes, rinse promptly and thoroughly with water.

Directions
  • Wet hands with water.
  • Press pump to dispense product into hands.
  • Massage soap into hands and wrists, emphasizing back of hands, knuckles and cuticles.
  • Rinse hands thoroughly and dry.
Active Ingredient

Benzalkonium Chloride 0.13%

Other Information (Other information)
  • Store at 20 to 25°C (68 to 77°F).
  • Do not freeze.
  • Dispose in accordance with all applicable federal, state and local regulations.
Inactive Ingredients

Water, Cetrimonium Chloride, Lauryl/Myristyl Amidopropyl Amine Oxide, Glycerin, Cocamide DIPA, PEG-120 Methyl Glucose Dioleate, Sodium Chloride, Fragrance, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Red 4, Yellow 5

Questions Or Comments? (Questions or comments?)

Call 1-877-I-BUY-ZEP (1-877-428-9937)

Stop Use and Ask Doctor (Stop use and ask doctor)

Stop use and ask doctor if skin irritation or redness persists for more than 72 hours.

When Using This Product (When using this product)
  • Do not swallow.
  • If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.
Keep Out of Reach of Children and Pets (Keep out of reach of children and pets)

Keep out of reach of children and pets. Children must be supervised in use of this product.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:54.935946 · Updated: 2026-03-14T23:11:54.825001