Active Ingredients
Colloidal Oatmeal 5%
Dermatitis Face Balm
FDA Label NDC 54291-040
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Canadian Custom Packaging Company for the product Dermatitis Face Balm (NDC 54291-040). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin protectant
Uses
Temporarily protects and helps relieve minor skin irritations and itching due to eczema, rash and dermatitis.
Warnings
For external use only.
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 - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Directions
Apply to affected areas as needed.
Other Information
STORE AT 65-75°F. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN TWO YEARS OF AGE AND OLDER.
Inactive Ingredients
Allantoin, Beeswax, butyrospermum parkii (shea) butter, glycine soja (soybean) oil, paraffin wax, petrolatum, prunus amygdalus dulcis (sweet almond) oil, simmondsia chinensis (jojoba) seed oil, tocopherol.
* Please review the disclaimer below.
