Drug Facts

Active Ingredients

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:
rashes
eczema
poison ivy, oak, or sumac
insect bites

Warnings:

For external use only

When using this product

do not get into eyes

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or beast-feeding,

ask a health professional before use.

Directions

Apply as needed

Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf (aloe Vera Gel) Juice, Arnica Montana Flower Extract, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceramide NG, Ceramide NP, Cetearyl Alcohol, Chamomilia Recutita (Chamomile) Extract, Citric Acid, dl-Panthenol, Ethylhexylglycerin, Euterpe Oleracea (Acai) Extract, Glycerin, Glyceryl Stearate, Hyaluronic Acid, Isopropyl Myristate, Magnesium Aluminum Silicate, Manuka Honey, Melaleuca Alternifolia (Tea Tree) Oil, Niacinamide, Linum Usitatissimum (Flaxseed) Oil, Oryza Sativa (Rice) Bran Oil, Passiflora Incarnata (Passion Fruit) Extract, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

Other Information:

Protect the product in this container from excessive heat and direct sun

Package Labeling:

Label

DERMOIA MANUKA HONEY ECZEMA CREAM
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83524-407
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE NG (UNII: C04977SRJ5)
CERAMIDE NP (UNII: 4370DF050B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMOMILE (UNII: FGL3685T2X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PANTHENOL (UNII: WV9CM0O67Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACAI (UNII: 46AM2VJ0AW)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYALURONIC ACID (UNII: S270N0TRQY)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
TEA TREE OIL (UNII: VIF565UC2G)
NIACINAMIDE (UNII: 25X51I8RD4)
FLAX SEED (UNII: 4110YT348C)
RICE BRAN OIL (UNII: LZO6K1506A)
AVOCADO OIL (UNII: 6VNO72PFC1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
JOJOBA OIL (UNII: 724GKU717M)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83524-407-00	120 mL in 1 JAR; Type 0: Not a Combination Product	06/05/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	06/05/2023

Labeler - TREASUREWISE LLC (112606067)

DERMOIA Manuka Honey Eczema Cream