SPL v1
SPL
SPL Set ID 5d6e6b4f-f0af-4068-9bda-736cbb54d931
Route
TOPICAL
Published
Effective Date 2020-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-10

Description

DRUG FACTS

Purpose

Antiseptic cleanser


Medication Information

Warnings and Precautions

Warnings

Purpose

Antiseptic cleanser

Description

DRUG FACTS

Uses:

Apply topically as needed as cleanse

Section 42229-5

DRUG FACTS

Section 50570-1

For external use on hands only. Stop use and ask a doctor if irritation develops.

Store and handling

Store in a cool place.

Section 51945-4

Directions

apply to skin as needed. Discard after single use.

Active Ingredient

Benzalkonium Chloride .......... 0.13 %

Inactive Ingredients:

Glycerol,1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium chloride, 2-propandiol, Antibacterial synerists, Stabilizer, Water

Keep Out of Reach of Children.

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


Structured Label Content

Uses:

Apply topically as needed as cleanse

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

DRUG FACTS

Section 50570-1 (50570-1)

For external use on hands only. Stop use and ask a doctor if irritation develops.

Store and handling

Store in a cool place.

Section 51945-4 (51945-4)

Purpose

Antiseptic cleanser

Directions

apply to skin as needed. Discard after single use.

Active Ingredient

Benzalkonium Chloride .......... 0.13 %

Inactive Ingredients:

Glycerol,1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium chloride, 2-propandiol, Antibacterial synerists, Stabilizer, Water

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)