FDA Label for Eczema
View Indications, Usage & Precautions
Eczema Product Label
The following document was submitted to the FDA by the labeler of this product Smith Amish, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts Active Ingredient
Colloidal Oatmeal 2.0%
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.
