MOUNTAIN ICE ECZEMA- colloidal oatmeal cream

Mountain Ice Eczema by

Drug Labeling and Warnings

Mountain Ice Eczema by is a Otc medication manufactured, distributed, or labeled by Mountainside Medical Equipment, Inc., Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Colloidal oatmeal 1%

Purpose

Skin Protectant

Uses:

Temporarily protects and helps relieve minor skin irritation and itching due to:

• Eczema
• Rashes

Warnings:

For external use only.

When using this product

• avoid contact with eyes.

Stop use and ask a doctor if

• Condition worsens.
• Symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out the reach of children.

If swallowed, seek medical attention or contact a Poison Control Center immediately.

Directions:

Apply as needed. Let product rest on the skin. Avoid drying soaps that can irritate the skin. Use daily for best results.

Other information:

For use on mild to moderate eczema or as directed by a physician. Store at room temperature. Avoid freezing.

Inactive Ingredients:

Water (Aqua), Paraffinum Liquidum (Mineral) Oil, Stearyl Alcohol, Cetearyl Alcohol, Glycerin, Propylene Glycol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Polysorbate 60, Actinidia Chinensis (Kiwi) Seed Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Hydrolyzed Collagen, Retinyl Palmitate, Ceramide NP, Ceramide AP, Ceramide EOP, Lactic Acid, Sodium Lauroyl Lactylate, Phytosphingosine, Cholesterol, Zea Mays (Corn) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Origanum Vulgare (Oregano) Oil, Curcuma Longa (Turmeric) Root Oil, Carbomer, Xanthan Gum, Citric Acid, Ethylhexylglycerin, Disodium EDTA, Sodium Hydroxide, Phenoxyethanol, Zinc Oxide (CI 77947).

Package/Label Principal Display Panel – Tube Label

MADE WITH SOLINE® AND SK-INFLUX® V MB TECHNOLOGY

MOUNTAIN ICE
ECZEMA CREAM

COLLAGEN, HYALURONIC ACID, TURMERIC, KIWI SEED OIL,
VITAMIN A, VITAMIN E, TEA TREE OIL, ZINC OXIDE, OREGANO OIL,
SUNFLOWER OIL, COLLOIDAL OATMEAL, ALOE VERA, CERAMIDE NP,
CERAMIDE AP, CERAMIDE EOP.

4 fl oz (118 g)

Questions? 1-888-687-4334

Distributed by:
Mountainside Medical
9262 Old River Road
Marcy, New York 13403
Family Owned and Operated
Service-Disabled Veteran

Package/Label Principal Display Panel – Packet Label

MOUNTAIN ICE
ECZEMA CREAM
MADE WITH SOLINE® AND SK-INFLUX® V MB TECHNOLOGY

Net Wt. 4 grams
www.MOUNTAIN-ICE.COM

Distributed by:
Mountainside Medical
Marcy, New York 13403

INGREDIENTS AND APPEARANCE

MOUNTAIN ICE ECZEMA 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72793-400
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 60 (UNII: CAL22UVI4M)
KIWI SEED OIL (UNII: O70FWV3WPP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CORN OIL (UNII: 8470G57WFM)
TEA TREE OIL (UNII: VIF565UC2G)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
TURMERIC OIL (UNII: 6KGS8SP16U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72793-400-01	118 g in 1 TUBE; Type 0: Not a Combination Product	02/18/2021
2	NDC: 72793-400-02	4 g in 1 PACKET; Type 0: Not a Combination Product	02/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/18/2021

Labeler - Mountainside Medical Equipment, Inc. (119735871)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	MANUFACTURE(72793-400)