SPL v3
SPL
SPL Set ID 116e2c97-2210-eb46-e063-6294a90a5454
Route
TOPICAL
Published
Effective Date 2024-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (0.001 g)
Inactive Ingredients
Calcium Chloride Anhydrous Rubidium Chloride Polyethylene Glycol 4000 Zinc Chloride Anhydrous Citric Acid Water Potassium Citrate Anhydrous Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-01

Description

Clean the affected area. Apply Xcellderma. Reapply after 24 hours.


Medication Information

Warnings and Precautions

Warnings: External use only. Avoid contact with eyes. Not to be applied over deep or puncture wounds, infections or lacerations. If condition worsens or does not improve within 7 days, stop use and consult a doctor.

Indications and Usage

Indications: To cover and protect abrasions, skin tears, pressure ulcers and minor burns.

Dosage and Administration

Clean the affected area. Apply Xcellderma. Reapply after 24 hours.

Description

Clean the affected area. Apply Xcellderma. Reapply after 24 hours.

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients: Polyethylene Glycol 4000, Polyethylene Glycol 400, Water, Citric Acid, Potassium Citrate, Benzoic Acid, Rubidium Chloride, Calcium Chloride.

Section 51945-4

Section 55105-1

To serve as a wound protectant


Structured Label Content

Indications and Usage (34067-9)

Indications: To cover and protect abrasions, skin tears, pressure ulcers and minor burns.

Dosage and Administration (34068-7)

Clean the affected area. Apply Xcellderma. Reapply after 24 hours.

Warnings and Precautions (34071-1)

Warnings: External use only. Avoid contact with eyes. Not to be applied over deep or puncture wounds, infections or lacerations. If condition worsens or does not improve within 7 days, stop use and consult a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients: Polyethylene Glycol 4000, Polyethylene Glycol 400, Water, Citric Acid, Potassium Citrate, Benzoic Acid, Rubidium Chloride, Calcium Chloride.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

To serve as a wound protectant


Advanced Ingredient Data


Raw Label Data

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