BALSHI MD CALMING HEMP SEED FOR ECZEMA RELIEF- oatmeal cream

BALSHI MD Calming Hemp Seed for Eczema Relief by

Drug Labeling and Warnings

BALSHI MD Calming Hemp Seed for Eczema Relief by is a Otc medication manufactured, distributed, or labeled by BALSHI MD DERMACEUTICALS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

ACTIVE INGREDIENT:

Colloidal Oatmeal 1.00%

Purpose

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:

INGREDIENTS AND APPEARANCE

BALSHI MD CALMING HEMP SEED FOR ECZEMA RELIEF 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71070-968
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER (UNII: 4VBL71TY4Y)
CHAMOMILE (UNII: FGL3685T2X)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LICORICE (UNII: 61ZBX54883)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
MENTHOL (UNII: L7T10EIP3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71070-968-03	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/01/2019

Labeler - BALSHI MD DERMACEUTICALS (010011434)