3e52df25-deca-07d1-e054-00144ff88e88

SPL v7
SPL
SPL Set ID 3e52df25-deca-07d1-e054-00144ff88e88
Route
topical
Published
Effective Date 2016-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
glycerin ditetracycline tetrasodium edetate methylchloroisothiazolinone water sodium laureth sulfate cocamidopropyl betaine sodium chloride anhydrous citric acid methylisothiazolinone fd&c yellow no. 5 fd&c red no. 4

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-10-08

Description

Benzalkonium Chloride - 0.13%


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Benzalkonium Chloride - 0.13%

Indications and Usage

Uses for handwashing or decrease bacteria to the skin

Dosage and Administration

Directions

  • Wet Hands
  • Apply palmful to hands
  • Scrub thoroughly
  • Rinse
Description

Benzalkonium Chloride - 0.13%

Section 50565-1

Keep out of reach of children

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

Section 50566-9

Stop use and ask a doctor if irritation or redness develops

Section 50567-7

When using the product

  • do not get into eyes. If contact occurs, rinse eye thoroughly with water
Section 51727-6

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl14700)

Section 51945-4

Section 55105-1

Purpose - Antibacterial


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Benzalkonium Chloride - 0.13%

Indications and Usage (34067-9)

Uses for handwashing or decrease bacteria to the skin

Dosage and Administration (34068-7)

Directions

  • Wet Hands
  • Apply palmful to hands
  • Scrub thoroughly
  • Rinse
Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops

Section 50567-7 (50567-7)

When using the product

  • do not get into eyes. If contact occurs, rinse eye thoroughly with water
Section 51727-6 (51727-6)

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl14700)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose - Antibacterial


Advanced Ingredient Data


Raw Label Data

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