Foaming Advanced Antibacterial Hand Soap

Foaming Advanced Antibacterial Hand Soap
SPL v1
SPL
SPL Set ID 75c6a1fa-9d19-6e01-e053-2a91aa0ac287
Route
TOPICAL
Published
Effective Date 2015-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.003 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Cocamidopropyl Pg-dimonium Chloride Phosphate Peg-6 Cocamide Laurtrimonium Chloride Methylisothiazolinone Iodopropynyl Butylcarbamate Fd&c Yellow No. 5 D&c Red No. 33 Aloe Vera Leaf .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-09-13

Description

Active Ingredient Benzalkonium Chloride 0.13% w/w


Medication Information

Warnings and Precautions

Warnings

For external use only. Avoid contact with eyes. If eye contact occurs, flush eyes with water.

Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.

Indications and Usage

Uses  Handwash to help decrease bacteria on the skin

Dosage and Administration

Directions  To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Description

Active Ingredient Benzalkonium Chloride 0.13% w/w

Section 50565-1

Keep out of reach of children. If swallowed, contact a physician or poison control center. 

Section 51727-6

Inactive Ingredients

water, cocamidopropyl betaine, cocamidopropyl PG-dimonium chloride phosphate, PEG-6 cocamide, laurtrimonium chloride, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), fragrance, iodopropynyl butylcarbamade, methylisothiazolinone, yellow 5, red 33.

Section 51945-4

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.13% w/w


Structured Label Content

Indications and Usage (34067-9)

Uses  Handwash to help decrease bacteria on the skin

Dosage and Administration (34068-7)

Directions  To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Warnings and Precautions (34071-1)

Warnings

For external use only. Avoid contact with eyes. If eye contact occurs, flush eyes with water.

Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, contact a physician or poison control center. 

Section 51727-6 (51727-6)

Inactive Ingredients

water, cocamidopropyl betaine, cocamidopropyl PG-dimonium chloride phosphate, PEG-6 cocamide, laurtrimonium chloride, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), fragrance, iodopropynyl butylcarbamade, methylisothiazolinone, yellow 5, red 33.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.13% w/w


Advanced Ingredient Data


Raw Label Data

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