SPL v3
SPL
SPL Set ID b62a0129-29de-3a27-e053-2a95a90a7f1a
Route
TOPICAL
Published
Effective Date 2020-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.12 g)
Inactive Ingredients
Sodium Laureth Sulfate Glycerin Cocamidopropyl Betaine Citric Acid Monohydrate Polysorbate 20 Methylchloroisothiazolinone/methylisothiazolinone Mixture Sodium Chloride D&c Red No. 33 Fd&c Blue No. 1 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-10

Description

BENZALKONIUM CHLORIDE 0.12%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

helps eliminate bacteria on hands

Dosage and Administration

Liquid.... Topical

Description

BENZALKONIUM CHLORIDE 0.12%

Section 50565-1

Except under adult supervision.

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

Section 50567-7

avoid contact with eyes.

In case of contact, flush with water.

Section 51727-6

Water, Sodium Lauryl Sulfate, Cocobetaine, Sodium Chloride, Glycerin USP,

Fragrance, Polysorbate 20, Methylchloroisotiazolinone/ Methylisotiazolinone, Citric

Acid, Color FD&C Blue # 1, Color FD&C Red # 33.

Section 51945-4

Hand Soap Antibacterial Fresh Scent

Hand Soap 250 ml- Dispensing

7.6 fl. oz (250 mL)

Section 55105-1

Purpose: Antibacterial

Section 55106-9

BENZALKONIUM CHLORIDE 0.12%

Section 59845-8

wash hands and rise.


Structured Label Content

Indications and Usage (34067-9)

helps eliminate bacteria on hands

Dosage and Administration (34068-7)

Liquid.... Topical

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Except under adult supervision.

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

Section 50567-7 (50567-7)

avoid contact with eyes.

In case of contact, flush with water.

Section 51727-6 (51727-6)

Water, Sodium Lauryl Sulfate, Cocobetaine, Sodium Chloride, Glycerin USP,

Fragrance, Polysorbate 20, Methylchloroisotiazolinone/ Methylisotiazolinone, Citric

Acid, Color FD&C Blue # 1, Color FD&C Red # 33.

Section 51945-4 (51945-4)

Hand Soap Antibacterial Fresh Scent

Hand Soap 250 ml- Dispensing

7.6 fl. oz (250 mL)

Section 55105-1 (55105-1)

Purpose: Antibacterial

Section 55106-9 (55106-9)

BENZALKONIUM CHLORIDE 0.12%

Section 59845-8 (59845-8)

wash hands and rise.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)