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NDC 50718-0011-01 Calm Eczema Therapy Cream 12 [hp_X]/mL Details
Calm Eczema Therapy Cream 12 [hp_X]/mL
Calm Eczema Therapy Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Kamedis. The primary component is SULFUR.
Product Information
NDC | 50718-0011 |
---|---|
Product ID | 50718-0011_46082fb0-0562-422a-b222-3bdd9e9657d8 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Calm Eczema Therapy Cream |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Sulphur 12X |
Product Type | HUMAN OTC DRUG |
Dosage Form | CREAM |
Route | TOPICAL |
Active Ingredient Strength | 12 |
Active Ingredient Units | [hp_X]/mL |
Substance Name | SULFUR |
Labeler Name | Kamedis |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | UNAPPROVED HOMEOPATHIC |
Application Number | n/a |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 50718-0011-01 (50718001101)
NDC Package Code | 50718-0011-1 |
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Billing NDC | 50718001101 |
Package | 1 TUBE in 1 CARTON (50718-0011-1) / 150 mL in 1 TUBE |
Marketing Start Date | 2018-01-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 304d3afc-dc81-4e8b-821c-47c5402ddf45 Details
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
Uses
• temporarily protects and helps relieve minor skin irritation and itching due to:
- rashes
- eczema
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
- adults and children 6 months of age and older
• apply twice daily or as needed
• massage cream into skin until fully absorbed - for babies under 6 months, consult a doctor
Inactive ingredients
acetylated lanolin alcohol, Baikal skullcap (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, mineral oil, Monnier's snowparsley (Cnidium monnieri) fruit extract, 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
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 150 mL Tube Carton
Kamedis®
Skin Restoring Solutions
BOTANIPLEX
TECHNOLOGY
CALM
Eczema
Therapy
Cream
SKIN TREATMENT
Clinically proven to reduce
eczema flare-ups. Relieves and
calms dry, itchy, irritated skin
due to eczema and rashes.
DERMATOLOGIST
RECOMMENDED
Shea butter, Ceramides,
Sulphur, free from Parabens,
Steroids, Dyes, Fragrance,
HOMEOPATHIC
150mL
5.07 fl oz

INGREDIENTS AND APPEARANCE
CALM ECZEMA THERAPY CREAM
sulphur 12x cream |
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Labeler - Kamedis (080311300) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Biogenesis Inc. | 069117328 | manufacture(50718-0011) |