Global Equipment F207

Global Equipment F207
SPL v5
SPL
SPL Set ID a72fb422-bcd8-d4d0-e053-2995a90a4c96
Route
TOPICAL
Published
Effective Date 2020-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.013 mg)
Inactive Ingredients
Cocamidopropyl Betaine Peg-7 Glyceryl Cocoate Phenoxyethanol Edetate Sodium Propylene Glycol 1,2-distearate .alpha.-tocopherol Acetate, D- Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-16

Description

Active Ingredient Benzalkonium Chloride 0.13% w/w


Medication Information

Warnings and Precautions

Warnings

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

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

Indications and Usage

Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Dosage and Administration

Directions

To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

Description

Active Ingredient Benzalkonium Chloride 0.13% w/w

Section 50565-1

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

Section 51727-6

Inactive Ingredients

Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, PEG-7 Glyceryl Cocoate, Fragrance, Phenoxyethanol, Tetrasodium EDTA.

Section 51945-4

Package Label

Section 55105-1

Purpose Antibacterial Agent

Section 55106-9

Active Ingredient Benzalkonium Chloride 0.13% w/w


Structured Label Content

Indications and Usage (34067-9)

Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease.

Dosage and Administration (34068-7)

Directions

To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

Warnings and Precautions (34071-1)

Warnings

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

Stop use if, in rare instances, redness or irritation develop. 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 poison control center.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, PEG-7 Glyceryl Cocoate, Fragrance, Phenoxyethanol, Tetrasodium EDTA.

Section 51945-4 (51945-4)

Package Label

Section 55105-1 (55105-1)

Purpose Antibacterial Agent

Section 55106-9 (55106-9)

Active Ingredient Benzalkonium Chloride 0.13% w/w


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)