SPL v3
SPL
SPL Set ID be8b96a2-c4a2-41f8-959b-0fe349cff37e
Route
TOPICAL
Published
Effective Date 2020-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Glycerin Witch Hazel Cocamidopropyl Betaine Dipropylene Glycol Aloe Vera Leaf Castanea Sativa Leaf Disodium Cocoamphodiacetate Chamaemelum Nobile Flower Calendula Arvensis Leaf Allantoin Sodium Benzoate Citric Acid Monohydrate Tocopherol Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-20

Description

Benzalkonium Chloride 0.13% w/w.

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13% w/w.

Use

To decrease bacteria on the skin.

Section 50565-1

Keep out of reach of childrenunless under adult supervision.

Warnings

For external use only.

When using this productdo not use in or near eyes. If contact occurs, flush thoroughly with water.

Stop useif irritation develops. If condition remains over 72 hours, contact a doctor.

Directions

Tear open package at edges, wipe down that dirty body ... yep ... even all those nooks and crannies chuck that wipe and get on with your day.

Active Ingredient

Benzalkonium Chloride 0.13% w/w.

Inactive Ingredients

Water, Glycerin, Waitch Hazel extract, Cocamidopropyl Betanine, Dipropylene Glycol, Aloe Vera leaf juice, Sweet Chestnut leaf extract, Disodium Cocoamphodiacetate, Chamomile flower extract, Calendula extract, Allantoin, Sodium Benzoate, Citric Acid, Tocopherol, Phenoxyethanol, Fragrance.

Package Label Principal Display Panel


Structured Label Content

Use

To decrease bacteria on the skin.

Section 50565-1 (50565-1)

Keep out of reach of childrenunless under adult supervision.

Purpose

Antibacterial

Warnings

For external use only.

When using this productdo not use in or near eyes. If contact occurs, flush thoroughly with water.

Stop useif irritation develops. If condition remains over 72 hours, contact a doctor.

Directions

Tear open package at edges, wipe down that dirty body ... yep ... even all those nooks and crannies chuck that wipe and get on with your day.

Active Ingredient

Benzalkonium Chloride 0.13% w/w.

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Waitch Hazel extract, Cocamidopropyl Betanine, Dipropylene Glycol, Aloe Vera leaf juice, Sweet Chestnut leaf extract, Disodium Cocoamphodiacetate, Chamomile flower extract, Calendula extract, Allantoin, Sodium Benzoate, Citric Acid, Tocopherol, Phenoxyethanol, Fragrance.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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