SPL v1
SPL
SPL Set ID 2699bc2e-73ee-42e1-b9fa-495f9f6b6efe
Route
TOPICAL
Published
Effective Date 2021-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.0013 1)
Inactive Ingredients
Water Aloe Vera Leaf Decyl Glucoside Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-04-01

Description

Benzalkonium chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%

Use(s)

■ For hand sanitizing to decrease bacteria on the skin.

■ Recommeded for repeated use.

Warnings

For external use only.

--------------------------------------------------------------------------------------------------------

When using this product avoid contact with the eyes. In case of contact, flush eyes thoroughly with water

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if irritation and redness develops and persists.

Directions

■ Take wipe from pouch & rub thoroughly over all surfaces of both hands.

■ Rub hands together briskly to dry.

■ Dispose of wipe

Active Ingredient

Benzalkonium chloride 0.13%

Other Information

■ Store below 110℉(43℃)

■ May discolor certain fabrics or surfaces.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Decyl Glucoside, Glycerin, Purified Water

Keep Out of Reach of Children

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

Package Label.principal Display Panel


Structured Label Content

Use(s)

■ For hand sanitizing to decrease bacteria on the skin.

■ Recommeded for repeated use.

Purpose (PURPOSE)

Antibacterial

Warnings (WARNINGS)

For external use only.

--------------------------------------------------------------------------------------------------------

When using this product avoid contact with the eyes. In case of contact, flush eyes thoroughly with water

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if irritation and redness develops and persists.

Directions

■ Take wipe from pouch & rub thoroughly over all surfaces of both hands.

■ Rub hands together briskly to dry.

■ Dispose of wipe

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium chloride 0.13%

Other Information (Other information)

■ Store below 110℉(43℃)

■ May discolor certain fabrics or surfaces.

Inactive Ingredients (INACTIVE INGREDIENTS)

Aloe Barbadensis Leaf Juice, Decyl Glucoside, Glycerin, Purified Water

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)