58345-105

58345-105
SPL v2
SPL
SPL Set ID 1c368292-4c33-8488-e063-6294a90a0fa9
Route
TOPICAL
Published
Effective Date 2024-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lactic Acid, L- (1.6 g)
Inactive Ingredients
Water Sodium Laureth Sulfate Direct Red 81 Sodium Hydroxide Cocamidopropyl Betaine Sodium Chloride Edetate Sodium Carmoisine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-02

Description

- L-(+)-lactic acid 1.6 %

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

- L-(+)-lactic acid 1.6 %

Use

To decrease bacteria on skin that could cause diseases.

Section 50565-1

Keep out of reach of children. If swallowed, seek inmediate medical attention or call a poison center.

Section 50566-9

Stop use if irritation or redness develop. If conditions persist for more than 72 hours, consult a doctor.

Section 51945-4

Warnings

- For external use only.

Directions

Wet hands thoroughly with product ant rise at the end.

Do Not Use

Do not use this product in or near the eyes.

Active Ingredients

- L-(+)-lactic acid 1.6 %

Inactive Ingredients

- Water

- Sodium Laureth Sulfate

- Sodium chloride

- Cocamidopropyl betaine

- Sodium hydroxide

- Tetrasodium EDTA

- Acid Red 14

- Direct Red 81


Structured Label Content

Use

To decrease bacteria on skin that could cause diseases.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, seek inmediate medical attention or call a poison center.

Section 50566-9 (50566-9)

Stop use if irritation or redness develop. If conditions persist for more than 72 hours, consult a doctor.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

- For external use only.

Directions

Wet hands thoroughly with product ant rise at the end.

Do Not Use (Do not use)

Do not use this product in or near the eyes.

Active Ingredients (Active ingredients)

- L-(+)-lactic acid 1.6 %

Inactive Ingredients (Inactive ingredients)

- Water

- Sodium Laureth Sulfate

- Sodium chloride

- Cocamidopropyl betaine

- Sodium hydroxide

- Tetrasodium EDTA

- Acid Red 14

- Direct Red 81


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)