Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)
BALSHI MD DERMACEUTICALS
TOPICAL
OTC DRUG
Temporarily protects and helps relieve minor skin irritation and ditching to due to Eczema or rashes.
OTC monograph final
BALSHI MD CALMING HEMP SEED FOR ECZEMA RELIEF- OATMEAL CREAM BALSHI MD DERMACEUTICALS _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- BALSHI MD CALMING HEMP SEED CREAM FOR ECZEMA RELIEF DRUG FACTS: ACTIVE INGREDIENT: Colloidal Oatmeal 1.00% PURPOS E Skin Protectant INDICATIONS: Temporarily protects and helps relieve minor skin irritation and ditching to due to Eczema or rashes. WARNINGS: For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician. KEEP OUT OF REACH OF CHILDREN. If swallowed, consult physician. DIRECTIONS: Adults and children two-years of age or older: Apply as needed. Children under two-years of age: consult a physician. ADDITIONAL INFORMATION: for use on mild to moderate Eczema or as directed by physician. Store at room temperature. OTHER INGREDIENTS: Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, a-Bisabalol, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cannabis Sativa (Hemp) Seed Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Chamomilla Recutita (Chamomile) Extract, Emu Oil, Emulsifying Wax NF, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Menthol, Phenoxyethanol, Potassium Sorbate, Xanthan Gum. PACKAGE LABELING: BALSHI MD CALMING HEMP SEED FOR ECZEMA RELIEF oatmeal cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:710 70 -9 6 8 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH O ATMEAL (UNII: 8 PI54V6 6 3Y) (OATMEAL - UNII:8 PI54V6 6 3Y) OATMEAL 10 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH ALLANTO IN (UNII: 344S277G0 Przeczytaj cały dokument