Soothing Incontinence Spray

Soothing Incontinence Spray
SPL v3
SPL
SPL Set ID d17a0c28-a5b7-4df0-e053-2995a90a8edd
Route
TOPICAL
Published
Effective Date 2021-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (59.8 g)
Inactive Ingredients
Ppg-15 Stearyl Ether Aloe 4-tert-butylcyclohexanol Pentylene Glycol Chamomile Sunflower Oil Polysorbate 80 Water Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-26

Description

Petrolatum 36%


Medication Information

Warnings and Precautions

For external use only.

Do not use on deep or puncture wounds.

When using this product avoid contact in eyes, rinse with water to remove, contents under pressure, do not puncture or incinerate, do not store at temperatures above 120F.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Indications and Usage

Temporarily protects and helps relieve chafed, chapped, or cracked skin.

Dosage and Administration

Shake well. Hold 4-6 inches from the skin and apply a thin continuous coating. Apply as needed.

Description

Petrolatum 36%

Section 50565-1

If swallowed, seek medical help or contact a Poison Control Center immediately.

Section 51727-6

4-t-Butylcyclohexanol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Helianthus Annuus (Sunflower) Seed Oil, Mineral Oil, Pentylene Glycol, PPG-15 Stearyl Ether.

Section 51945-4

Section 53414-9

Ask a healthcare or professional before use.

Section 55105-1

Skin Protectant

Section 55106-9

Petrolatum 36%


Structured Label Content

Indications and Usage (34067-9)

Temporarily protects and helps relieve chafed, chapped, or cracked skin.

Dosage and Administration (34068-7)

Shake well. Hold 4-6 inches from the skin and apply a thin continuous coating. Apply as needed.

Warnings and Precautions (34071-1)

For external use only.

Do not use on deep or puncture wounds.

When using this product avoid contact in eyes, rinse with water to remove, contents under pressure, do not puncture or incinerate, do not store at temperatures above 120F.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

If swallowed, seek medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

4-t-Butylcyclohexanol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Helianthus Annuus (Sunflower) Seed Oil, Mineral Oil, Pentylene Glycol, PPG-15 Stearyl Ether.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a healthcare or professional before use.

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Petrolatum 36%


Advanced Ingredient Data


Raw Label Data

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