ECZEMA AND PSORIASIS THERAPY - fucus vesiculosus, centella asiatica, melissa officinalis, aloe soap

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

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Active ingredient:
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M), CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U), MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N), ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)
Available from:
Sundial Group LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses: Temporarily protects and helps relieve minor skin irritation and itching due to: rash, eczema, poison ivy, oak or sumac, insect bites.
Authorization status:
unapproved homeopathic
Authorization number:
58666-3122-6

ECZEMA AND PSORIASIS THERAPY - fucus vesiculosus, centella asiatica, melissa officinalis,

aloe soap

Sundial Group LLC

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.

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Eczema and Psoriasis Therapy

Drug Facts

Active Ingredients

Purpose

Fucus Vesiculosus Extract - (Tinc)

Remedy for eczema

Centella Asiatica Extract - (Tinc)

Reduces itching

Melissa Officinalis Extract - (Tinc)

Reduces irritation

Aloe Socotrina Extract - (1X)

Humectant

Uses: Temporarily protects and helps relieve minor skin irritation and itching due to: rash, eczema,

poison ivy, oak or sumac, insect bites.

Warnings:For external use only.

Not to be used during pregnancy. Not to be used while nursing.

Therapeutic use is not recommended in hyperthyroidism; long-term therapeutic use is not recommended.

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: Lather in hands or on a washcloth and wash entire body. Rinse thoroughly. Gentle enough

for the face and for daily use.

Other information: For use on mild to moderate eczema or psoriasis, or as directed by a physician.

Inactive ingredients: Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Palmitic

Acid, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus, (Sunflower) Seed Oil (and) Salix Alba

(Willow) Bark Extract, Saponified Butyrospermum Parkii (Shea) Butter, Saponified Cocos Nucifera,

(Coconut) Oil, Saponified Elaeis Guineensis (Palm) Kernel Oil, Cocoa Pod Ash, Avena Sativa (Oat)

Kernel Meal, Carbon, Avena Sativa (Oat) Kernel Flour, Melaleuca Alternifolia (Tea Tree) Leaf Oil,

Sodium Chloride, Tetrasodium EDTA, Tetrasodium Etidronate.

*Certified Organic Ingredient

Questions? 631-842-8800 or visit www.SheaMoisture.com

ECZEMA AND PSORIASIS THERAPY

fucus vesiculosus, centella asiatica, melissa officinalis, aloe soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 6 6 6 -3122

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

FUCUS VESICULO SUS (UNII: 535G2ABX9 M) (FUCUS VESICULOSUS -

UNII:535G2ABX9 M)

FUCUS VESICULOSUS 1 [hp_X] in 1 g

CENTELLA ASIATICA (UNII: 7M8 6 7G6 T1U) (CENTELLA ASIATICA - UNII:7M8 6 7G6 T1U)

CENTELLA ASIATICA

1 [hp_X] in 1 g

MELISSA O FFICINALIS (UNII: YF70 18 9 L0 N) (MELISSA OFFICINALIS - UNII:YF70 18 9 L0 N)

MELISSA OFFICINALIS 1 [hp_X] in 1 g

ALO E (UNII: V5VD430 YW9 ) (ALOE - UNII:V5VD430 YW9 )

ALOE

1 [hp_X] in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM PALM KERNELATE (UNII: 6 H9 1L1NXTW)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

Sundial Group LLC

PALMITIC ACID (UNII: 2V16 EO9 5H1)

SHEA BUTTER (UNII: K49 155WL9 Y)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

SALIX ALBA BARK (UNII: 20 5MXS71H7)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

PALM O IL (UNII: 5QUO0 5548 Z)

CO CO A (UNII: D9 10 8 TZ9 KG)

O ATMEAL (UNII: 8 PI54V6 6 3Y)

ACTIVATED CHARCO AL (UNII: 2P3VWU3H10 )

TEA TREE O IL (UNII: VIF56 5UC2G)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

ETIDRO NATE TETRASO DIUM (UNII: CZZ9 T1T1X4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 6 6 6 -3122-6

141 g in 1 PACKAGE

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 6 /0 1/20 13

Labeler -

Sundial Group LLC (832783430)

Revised: 6/2013

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