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SPL v3
SPL
SPL Set ID 5200aee3-7afe-3344-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2023-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Water Sodium Palmate Sodium Palm Kernelate Glycerin Caramel Sodium Chloride Sodium Lauryl Sulfate Titanium Dioxide Coconut Acid Citric Acid Monohydrate Etidronic Acid Edetate Sodium Fd&c Green No. 3 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-15

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses for washing to decrease bacteria on the skin

Dosage and Administration

Directions

  • Wet bar with water.
  • Lather vigorously and wash skin.
  • Rinse and dry thoroughly.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if irritation or redness develop

Section 50567-7

When using this product do not use in or near the eyes, in case of eye contact, flush with water

Section 51727-6

Inactive ingredients Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Chloride, Sodium Lauryl Sulfate, Fragrance, Titanium Dioxide, Coconut Acid, Citric Acid, Etidronic Acid, Tetrasodium EDTA, Green 3, Red 33. May contain Caramel.

Section 51945-4

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Anti-bacterial

Deodorant

Sport Bar

Contains no animal fat

NET WT 5 OZ (142g)

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active ingredient

Benzalkonium Chloride 0.1%


Structured Label Content

Indications and Usage (34067-9)

Uses for washing to decrease bacteria on the skin

Dosage and Administration (34068-7)

Directions

  • Wet bar with water.
  • Lather vigorously and wash skin.
  • Rinse and dry thoroughly.
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develop

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes, in case of eye contact, flush with water

Section 51727-6 (51727-6)

Inactive ingredients Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Chloride, Sodium Lauryl Sulfate, Fragrance, Titanium Dioxide, Coconut Acid, Citric Acid, Etidronic Acid, Tetrasodium EDTA, Green 3, Red 33. May contain Caramel.

Section 51945-4 (51945-4)

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Anti-bacterial

Deodorant

Sport Bar

Contains no animal fat

NET WT 5 OZ (142g)

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium Chloride 0.1%


Advanced Ingredient Data


Raw Label Data

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