50563-367_g0xabw05

50563-367_g0xabw05
SPL v1
SPL
SPL Set ID 617b94a9-7323-41bc-a476-a4ae3b5f341f
Route
TOPICAL
Published
Effective Date 2020-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (3.6 mg)
Inactive Ingredients
Glycerin Ethylhexylglycerin Aloe Vera Leaf Phenoxyethanol Propylene Glycol Water Mentha Arvensis Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-20

Description

Benzalkonium Chloride 0.1%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.1%

Use

■ To decrease bacteria on hands

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Section 50567-7

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 51945-4

Warnings

For external use only

Directions

For adults and children two years and over

Peel over reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry. 

Place used wipes in to waste basket.  Do not flush.

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Mentha Arvensis Leaf Extract, Phenoxyethanol, Propylene Glycol, Water


Structured Label Content

Use

■ To decrease bacteria on hands

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Section 50567-7 (50567-7)

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings (WARNINGS)

For external use only

Directions

For adults and children two years and over

Peel over reusable label and remove a wipe from the packet.

Wet hands thoroughly and air dry. 

Place used wipes in to waste basket.  Do not flush.

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Fragrance, Glycerin, Mentha Arvensis Leaf Extract, Phenoxyethanol, Propylene Glycol, Water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)