53c13b0c-9c2c-49f1-e054-00144ff88e88

SPL v1
SPL
SPL Set ID 53c13b0c-9c2c-49f1-e054-00144ff88e88
Route
topical
Published
Effective Date 2017-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
d&c red no. 33 fd&c blue no. 1 sodium chloride anhydrous citric acid glycerin etidronate tetrasodium methylchloroisothiazolinone water sodium laureth sulfate cocamidopropyl betaine methylisothiazolinone

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-07-07

Description

Active Ingredient - Benzalkonium Chloride - 0.13%


Medication Information

Warnings and Precautions

for external use only - hands only

Active Ingredient

Active Ingredient - Benzalkonium Chloride - 0.13%

Indications and Usage

Use for handwashing to decrease bacteria on skin

Dosage and Administration

Direction

* wet hands

* apply to hands

* scrub thoroughly

* rinse thoroughly

Description

Active Ingredient - Benzalkonium Chloride - 0.13%

Section 50565-1

keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9

Stop use and ask a doctor if irritation or redness develops and if condition persists for more than 72 hours

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Section 51727-6

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Tetra Sodium EDTA, Methylchloroisothiazolinone, Methylisthiazolinone, Red # 33 (Cl 17200), Blue# 1(42090), Fragrance (Parfum)

Section 51945-4

Section 55105-1

Purpose - Antibacterial


Structured Label Content

Warnings and Precautions (34071-1)

for external use only - hands only

Active Ingredient (55106-9)

Active Ingredient - Benzalkonium Chloride - 0.13%

Indications and Usage (34067-9)

Use for handwashing to decrease bacteria on skin

Dosage and Administration (34068-7)

Direction

* wet hands

* apply to hands

* scrub thoroughly

* rinse thoroughly

Section 50565-1 (50565-1)

keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops and if condition persists for more than 72 hours

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Section 51727-6 (51727-6)

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Tetra Sodium EDTA, Methylchloroisothiazolinone, Methylisthiazolinone, Red # 33 (Cl 17200), Blue# 1(42090), Fragrance (Parfum)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose - Antibacterial


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)