Active Ingredients
Lanolin 15.5%
Petrolatum 53.4%
Fds Intimate Whole Body Medicated Chafing Ointment
FDA Label NDC 65197-730
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 Fds Intimate Whole Body Medicated Chafing (NDC 65197-730). 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 prevent and temporarily protects chafed, chapped or cracked skin
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
apply as needed
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 FDSforHer.com
Distributed By:
WellSpring Pharmaceutical Corporation
Sarasota, FL 34243
© 2024 WellSpring Pharmaceutical Corporation
Package Label. Principal Display Panel
FDS intimate Whole Body Medicated Chafing Ointment 1.5 oz (42.5g)
HELPS PREVENT AND TREAT Chafing
Enriched with Vitamins A+D
Non-Irritating
Odor Control Technology
NET WT 1.5 oz (42.5g)
CT70030A
NDC# 65197-730-15
P13058.00
Carton (FDS intimate Whole Body Medicated Chafing Ointment1.5 oz (42.5g))
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