Drug Facts Active Ingredient
Colloidal Oatmeal 2.0%
Eczema Cream
FDA Label NDC 72609-704
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smith Amish, Llc for the product Eczema (NDC 72609-704). 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 drug facts active ingredient, purpose, uses, warnings, otc - stop use, otc - pregnancy or breast feeding, keep out of reach of children., directions, 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 irritation and itching due to eczema.
Warnings
- For external use only
- When using this product do not get into eyes
Otc - Stop Use
- If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,, discontinue use of this product and consult a doctor.
- Do not apply to wounds or damaged skin.
- Do not bandage tightly.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 5 years and over apply gently to the affected area as needed. Not recommended for face.
Other Information
Protect from excessive heat
Store at 20-25 oC (68-77F)
Inactive Ingredients
Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, eucalyptus (Eucalyptus cinerea), glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, rosemary (Rosmariunus officinalis) oil, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water
Questions?
Call (866) 419-3567
Monday through Friday 8:00am - 2:00pm ET
Other
Tamper evident: Do not use if safety seal under cap is broken or missing.
Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634
Label
Smith Amish Eczema Cream (72609-704-02)
Deep Moisturizing Cream
for sensitive, distressed, dry, scaly skin
Clean Fresh Scent
Easily Absorbed and Non-Greasy
Net wt. 2oz (59g)
* Please review the disclaimer below.
