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NDC 50718-0012-01 Calm Eczema Therapy Wash 12 [hp_X]/mL Details

Calm Eczema Therapy Wash 12 [hp_X]/mL

Calm Eczema Therapy Wash is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Kamedis. The primary component is SULFUR.

Product Information

NDC	50718-0012
Product ID	50718-0012_502dc5e6-4608-4e2a-9db0-16d7284a7f3b
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 Wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sulphur 12X
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
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 50718-0012-01 (50718001201)

Pricing Information	N/A
NDC Package Code	50718-0012-1
Billing NDC	50718001201
Package	1 TUBE in 1 CARTON (50718-0012-1) / 200 mL in 1 TUBE
Marketing Start Date	2018-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 38a3495e-6872-4cb8-bab7-1c93e1470e2c 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

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

adults and children 6 months of age and older

• squeeze wash onto wet hands and work into a rich, creamy lather

• wash face and body, then rinse
for babies under 6 months, consult a doctor

Inactive Ingredients

allantoin, ammonium laureth sulfate, Chinese rhubarb (Rheum palmatum) root extract, citric acid, common purslane (Portulaca oleracea) extract, decyl glucoside, disodium laureth sulfosuccinate, glycerin, PEG-150 distearate, pentadecalactone, polyquaternium-10, sodium benzoate, sodium cocoamphoacetate, soapberry (Sapindus mukurossi) fruit extract, water

Questions or Comments?

1-855-626-6606

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

CALM ECZEMA THERAPY WASH

sulphur 12x liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50718-0012
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50718-0012-1	1 in 1 CARTON	01/01/2018
1		200 mL in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - Kamedis (080311300)

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

Revised: 6/2020

Document Id: 502dc5e6-4608-4e2a-9db0-16d7284a7f3b

Set id: 38a3495e-6872-4cb8-bab7-1c93e1470e2c

Version: 3

Effective Time: 20200624