NDC Code(s) : 50718-0012-1
Packager : Kamedis

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Calm Eczema Therapy WashSulphur 12X LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50718-0012
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFUR(UNII: 70FD1KFU70)
(SULFUR - UNII:70FD1KFU70) 		SULFUR12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN(UNII: 344S277G0Z)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
DISODIUM LAURETH SULFOSUCCINATE(UNII: D6DH1DTN7E)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-150 DISTEARATE(UNII: 6F36Q0I0AC)
PENTADECALACTONE(UNII: OK17S3S98K)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM COCOAMPHOACETATE(UNII: W7Q5E87674)
WATER(UNII: 059QF0KO0R)
RHEUM PALMATUM ROOT(UNII: G025DAL7CE)
SAPINDUS MUKOROSSI FRUIT(UNII: 66H9NW427Y)
PURSLANE(UNII: M6S840WXG5)
AMMONIUM LAURETH-2 SULFATE(UNII: 698O4Z48G6)
POLYQUATERNIUM-10 (10000 MPA.S AT 2%)(UNII: PI1STR9QYH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50718-0012-1200 mL in 1 TUBE Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 01/01/2018

LABELER - Kamedis(080311300)

Establishment
Name Address ID/FEI Business Operations
Biogenesis Inc. 069117328 manufacture(50718-0012)

PRINCIPAL DISPLAY PANEL

Kamedis®
Skin Restoring Solutions

CALM
Eczema Therapy
Wash

SKIN TREATMENT
Gentle foaming cleanser for
dry, red, itchy skin due to
eczema.

DERMATOLOGIST
RECOMMENDED
With Allantoin, Glycerin,
Sulphur. Free from
Parabens, Steroids, Dyes,
Fragrance. Safe for babies.
HOMEOPATHIC

BOTANIPLEX
TECHNOLOGY

PRINCIPAL DISPLAY PANEL - 200 mL Tube Label