50563-370_hgkths07

50563-370_hgkths07
SPL v1
SPL
SPL Set ID 0f5b01bf-ddf3-488a-b928-0f88e75bc66c
Route
topical
Published
Effective Date 2020-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (5.4 mg)
Inactive Ingredients
glycerin ethylhexylglycerin phenoxyethanol propylene glycol water lemon juice

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-10-28

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.1%


Medication Information

Warnings

For external use only

Purpose

Antibacterial

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.

Inactive Ingredients

Citrus Medica Limonum (Lemon) Fruit Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

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

Active Ingredient

Benzalkonium Chloride 0.1%


Structured Label Content

Warnings (WARNINGS)

For external use only

Purpose

Antibacterial

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.

Inactive Ingredients (Inactive ingredients)

Citrus Medica Limonum (Lemon) Fruit Extract, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Propylene Glycol, Water

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)

Active Ingredient

Benzalkonium Chloride 0.1%


Advanced Ingredient Data


Raw Label Data

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