Active Ingredients
Dimethicone 28%
Petrolatum 48%
Dr. Mom Butt Balm Ointment
FDA Label NDC 0496-0590
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ferndale Laboratories, Inc. for the product Dr. Mom Butt Balm (NDC 0496-0590). 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
Dimethicone 28%..........Skin protectant
Petrolatum 48%............Skin protectant
Uses
- helps prevent and temporarily protects and helps relieve 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 at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Inactive Ingredients
aluminum starch octenylsuccinate, fractionated coconut oil, magnesium hydroxide, spearmint oil
Questions?
Toll free (888) 548-0900
Package Display
Dr. Mom Butt Balm Carton (Drmombuttbalmcarton)
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