Active Ingredients
Lanolin 15.5%
Petrolatum 53.4%
Ad Skin Protectant Ointment
FDA Label NDC 65197-470
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wellspring Pharmaceutical Corporation for the product Ad Skin Protectant (NDC 65197-470). 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 active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, do not use on, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Skin protectant
Uses
- helps treat and prevent incontinence rash
- protects chafed skin associated with incontinence rash and helps seal out wetness
- temporarily protects and helps relieve chapped or cracked skin and lips
Warnings
For external use only
When Using This Product
- do not get into eyes
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
Do Not Use On
- deep or puncture wounds
- animal bites
- serious burns
Keep Out Of Reach Of Children
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- for skin protectant use: apply as needed
- for incontinence rash:
- change wet and soiled undergarments promptly
- gently cleanse affected skin, and allow skin to dry
- apply ointment liberally as often as necessary, with each undergarment change, especially at bedtime or any time when exposure to wetness may be prolonged
Other Information
store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
mineral oil, paraffin, microcrystalline wax, cod liver oil (contains vitamin A & vitamin D), fragrance
Questions?
1-844-241-5454 or ADskinhealth.com
Distributed By:
WellSpring Pharmaceutical Corporation
Sarasota, FL 34243
© 2024 WellSpring Pharmaceutical Corporation
Package Label. Principal Display Panel
A+D Incontinence Support Ointment 3.5oz
Skin Protectant & Rash Ointment
PROTECTS, SOOTHES & NOURISHES IRRITATED SKIN with Vitamins A+D
Protects skin instantly by forming a barrier to lock out moisture
With Odor Neutralizing Technology
PEDIATRICIAN RECOMMENDED
NET WT 3.5oz (99g)
CT40700A
NDC# 65197-407-35
P13043.00
A+d Incontinence Support Ointment 3.5oz (Ad Incontinence Support Ointment 1)
* Please review the disclaimer below.
