CALM ECZEMA THERAPY CREAM- sulphur 12x cream

Calm Eczema Therapy Cream by

Drug Labeling and Warnings

Calm Eczema Therapy Cream by is a Homeopathic medication manufactured, distributed, or labeled by Kamedis, Biogenesis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Sulphur 12X HPUS*
* The letters ‘HPUS’ indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

Purpose

Skin Treatment

Use

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

• rashes
• eczema

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

Directions

• Apply as needed

Inactive Ingredients

Acetylated Lanolin Alcohol, Baikal Skulcap (Scutellaria Baicalensis) Root Extract, Benzyl Alcohol, Caprylic/Capric Triglyceride, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cetearyl Alcohol, Cetearyl Ethylhexanoate, Cetearyl Glucoside, Cetyl Acetate, Cetyl Alcohol, Chinese Rhubarb (Rheum Palmatum) Root Extract, Cholesterol, Dehydroacetic Acid, Dimethicone, Glycerin, Glyceryl Stearate, Great Burnet (Sanguisorba Officinalis) Root Extract, Hyaluronic Acid, Lactic Acid, Licorice (Glycyrrhiza Glabra) Root Extract, Magnesium Aspartate, Monnier's Snowparsley (Cnidium Monnieri) Fruit Extract, Mineral Oil, Oleyl Acetate, PEG-100 Stearate, Petrolatum, Phytosphingosine, Potassium Aspartate, Potassium Sorbate, Propylene Glycol, Sarcosine, Shea Butter (Butyrospermum Parkii), Sodium Cocoyl Amino Acids, Sodium Lauroyl Lactylate, Stearyl Acetate, Sucrose Stearate, Tree of Heaven (Ailanthus Altissima) Bark Extract, Vitamin E (Tocopheryl Acetate), Water, Xanthan Gum.

Questions or Comments?

1-855-626-6606

SPL UNCLASSIFIED SECTION

Made in USA
Manufactured for Kamedis, New Jersey 07601
1-855-626-6606

www.kamedis-usa.com

Carton label

INGREDIENTS AND APPEARANCE

CALM ECZEMA THERAPY CREAM 
sulphur 12x cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50718-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE NP (UNII: 4370DF050B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETYL ACETATE (UNII: 4Q43814HXS)
CETYL ALCOHOL (UNII: 936JST6JCN)
RHEUM PALMATUM ROOT (UNII: G025DAL7CE)
CHOLESTEROL (UNII: 97C5T2UQ7J)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
HYALURONIC ACID (UNII: S270N0TRQY)
LACTIC ACID (UNII: 33X04XA5AT)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
MINERAL OIL (UNII: T5L8T28FGP)
9-OCTADECENYL ACETATE, (9Z)- (UNII: EU1ETP025C)
PEG-100 STEARATE (UNII: YD01N1999R)
PETROLATUM (UNII: 4T6H12BN9U)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
POTASSIUM ASPARTATE (UNII: OC4598NZEQ)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SARCOSINE (UNII: Z711V88R5F)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
STEARYL ACETATE (UNII: A8005KSX95)
SUCROSE STEARATE (UNII: 274KW0O50M)
AILANTHUS ALTISSIMA BARK (UNII: 5YM66ALY0U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
sodium cocoyl wheat amino acids (UNII: JW3VT57I11)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50718-0011-1	1 in 1 CARTON	01/01/2018
1		150 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2018

Labeler - Kamedis (533176319)

Establishment
Name	Address	ID/FEI	Business Operations
Biogenesis Inc.		069117328	manufacture(50718-0011)