CALM ECZEMA THERAPY CREAM- sulphur 12x cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)
Available from:
Kamedis
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
unapproved homeopathic
Authorization number:
50718-0011-1

CALM ECZEMA THERAPY CREAM- sulphur 12x cream

Kamedis

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for

safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Calm Eczema Therapy Cream

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

Purpos e

Skin Treatment

Us es

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

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

Questions or Comments?

1-855-626-6606

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Made in USA

(US and non-US ingredients)

Manufactured for Kamedis

Paterson, NJ 07503

1-855-626-6606

www.KamedisUSA.com

Carton label

CALM ECZEMA THERAPY CREAM

sulphur 12x cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 718 -0 0 11

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 )

SULFUR

12 [hp_X] in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ACETYLATED LANO LIN ALCO HO LS (UNII: SNN716 8 10 P)

SCUTELLARIA BAICALENSIS RO O T (UNII: 7J9 5K7ID2S)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

CERAMIDE AP (UNII: F1X8 L2B0 0 J)

CERAMIDE 1 (UNII: 5THT33P7X7)

CERAMIDE NP (UNII: 4370 DF0 50 B)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CETEARYL ETHYLHEXANO ATE (UNII: 9 M6 4UO4C25)

CETEARYL GLUCO SIDE (UNII: 0 9 FUA47KNA)

CETYL ACETATE (UNII: 4Q438 14HXS)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

RHEUM PALMATUM RO O T (UNII: G0 25DAL7CE)

CHO LESTERO L (UNII: 9 7C5T2UQ7J)

DEHYDRO ACETIC ACID (UNII: 2KAG279 R6 R)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL STEARATE SE (UNII: FCZ5MH78 5I)

SANGUISO RBA O FFICINALIS RO O T (UNII: 4NYV2HT0 1X)

HYALURO NIC ACID (UNII: S270 N0 TRQY)

LACTIC ACID (UNII: 33X0 4XA5AT)

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H)

MAGNESIUM ASPARTATE (UNII: R17X8 20 ROL)

CNIDIUM MO NNIERI FRUIT (UNII: V1IA3S3CUS)

MINERAL O IL (UNII: T5L8 T28 FGP)

9 -O CTADECENYL ACETATE, ( 9 Z) - (UNII: EU1ETP0 25C)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PETRO LATUM (UNII: 4T6 H12BN9 U)

PHYTO SPHINGO SINE (UNII: GIN46 U9 Q2Q)

PO TASSIUM ASPARTATE (UNII: OC459 8 NZEQ)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SARCO SINE (UNII: Z711V8 8 R5F)

SHEA BUTTER (UNII: K49 155WL9 Y)

SO DIUM LAURO YL LACTYLATE (UNII: 7243K8 5WFO)

STEARYL ACETATE (UNII: A8 0 0 5KSX9 5)

Kamedis

SUCRO SE STEARATE (UNII: 274KW0 O50 M)

AILANTHUS ALTISSIMA BARK (UNII: 5YM6 6 ALY0 U)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

WATER (UNII: 0 59 QF0 KO0 R)

XANTHAN GUM (UNII: TTV12P4NEE)

so dium co co yl whea t a mino a cids (UNII: JW3VT57I11)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 718 -0 0 11-1

1 in 1 CARTON

0 1/0 1/20 18

1

150 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 1/0 1/20 18

Labeler -

Kamedis (080311300)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bio genesis Inc.

0 6 9 117328

ma nufa c ture (50 718 -0 0 11)

Revised: 6/2020

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