Otc - Active Ingredient
Petrolatum 36%
Dr. Butler Soothing Incontinence Spray
FDA Label NDC 70942-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beyond Health P.a. for the product Dr. Butler Soothing Incontinence (NDC 70942-017). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
Indications & Usage
Temporarily protects and helps relieve chafed, chapped, or cracked skin.
Warnings
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.
Otc - Pregnancy Or Breast Feeding
Ask a healthcare or professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, seek medical help or contact a Poison Control Center immediately.
Dosage & Administration
Shake well. Hold 4-6 inches from the skin and apply a thin continuous coating. Apply as needed.
Inactive Ingredient
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.
Package Label.Principal Display Panel
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