ECZEMA RESCUE- carbolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor l

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

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Active ingredient:
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV), FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N), GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV), CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U), JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105), JUGLANS REGIA FRUIT RIND, IMMATURE (UNII: ZPS7Q5U53K) (JUGLANS REGIA FRUIT RIND, IMMATURE - UNII:ZPS7Q5U53K), VINCA MINOR (UNII: WGM46PQF02) (VINCA MINOR
Available from:
Peaceful Mountain, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
May temporarily relieve minor symptoms of eczema. • Irritated • Red • Burning • Itching • Dry • Rough • Scaly • Chapped • Cracked skin • Rashes • Urticaria (hives) • Eruptions •  Skin Inflammation • Generally unhealthy skin.** **Claims based on traditional homeopathic practic, not accepted medical evidence. Not FDA evaluated. May temporarily relieve minor symptoms of eczema. • Irritated • Red • Burning • Itching • Dry • Rough • Scaly • Chapped • Cracked skin • Rashes • Urticaria (hives) • Eruptions • Skin Inflammation • Generally unhealthy skin.** **Claims based on traditional homeopathic practic, not accepted medical evidence. Not FDA evaluated.
Authorization status:
unapproved homeopathic
Authorization number:
43846-0008-1, 43846-0008-2

ECZEMA RESCUE- carbolicum acidum, fagopyrum esculentum, hydrastis canadensis,

hydrocotyle asiatica, juglans regia, vinca minor lotion

Peaceful Mountain, Inc.

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.

----------

Drug Facts:

ACTIVE INGREDIENTS:

(in lotion): 0.15% of Carbolicum Acidum 30X, Fagopyrum Esculentum 30X, Hydrastis Canadensis 30X,

Hydrocotyle Asiatica 30X, Juglans Regia 30X, Vinca Minor 30X

INDICATIONS:

May temporarily relieve minor symptoms of eczema. Irritated Red Burning Itching Dry Rough

Scaly Chapped Cracked skin Rashes Urticaria (hives) Eruptions Skin Inflammation

Generally unhealthy skin.**

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

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

Allergy alert:Macadamia and Kukui Nut Oils Soy

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

right away.

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

DIRECTIONS:

Apply at least 3 times daily over affected area. For external use only.

Children under 12 years of age: Consult a doctor.

INDICATIONS:

May temporarily relieve minor symptoms of eczema. Irritated Red Burning Itching Dry Rough

Scaly Chapped Cracked skin Rashes Urticaria (hives) Eruptions Skin Inflammation

Generally unhealthy skin.**

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

INACTIVE INGREDIENTS:

Purified Water, Poke (Berry) Phytolacca Americana, Olive Oil (Olea Europaea), Avocado Oil (Persea

Americana), Macadamia Nut Oil (Macadamia Integrifolia), Phenoxyethanol, Caprylyl Glycol, Sorbic

Acid, Acrylates/C10-30alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, PEG-33, PEG-8

Dimethicone, PEG-14, Kukui Nut Oil (Aleurites Moluccana, Polysorbate 20, Chaparral (Leaf) Larrea

Tridentata, Poke (Root) Phytolacca Americana, Sodium Hydroxide (Solution), Arnica (Flower) Arnica

Montana, St. John’s Wort (Aerial Parts) Hypericum Perforatum, White Willow (Bark) Salix Alba,

Bloodroot (Root) Sanguinaria Canadensis, Comfrey (Leaf) Symphytum Officinale, Ascorbic Acid

(Vitamin C Powder), Neem (Leaf) Azadirachta Indica, Calendula (Flower) Calendula Officinalis,

Tocopherols (Vitamin E Oil) From Soy, Edetate Disodium (EDTA), Oregano, Potassium Sorbate

QUESTIONS:

Dist. by Peaceful Mountain, Inc., Woodbine, IA 51579

888-303-3388 Mon thru Fri 8 a.m. - 5 p.m. CST

www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

eczema rescue

soothing rash relief

homeopathic

lotion

Net wt. 1 oz. (28 g)

ECZEMA RESCUE

carbolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor

lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:438 46 -0 0 0 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHENO L (UNII: 339 NCG44TV) (PHENOL - UNII:339 NCG44TV)

PHENOL

30 [hp_X]

in 1 g

FAGO PYRUM ESCULENTUM (UNII: B10 M6 9 172N) (FAGOPYRUM ESCULENTUM -

UNII:B10 M6 9 172N)

FAGOPYRUM

ESCULENTUM

30 [hp_X]

in 1 g

GO LDENSEAL (UNII: ZW3Z11D0 JV) (GOLDENSEAL - UNII:ZW3Z11D0 JV)

GOLDENSEAL

30 [hp_X]

in 1 g

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

CENTELLA ASIATICA

30 [hp_X]

in 1 g

JUGLANS REGIA LEAF (UNII: 8 5HKB8 710 5) (JUGLANS REGIA LEAF -

UNII:8 5HKB8 710 5)

JUGLANS REGIA LEAF

30 [hp_X]

in 1 g

JUGLANS REGIA FRUIT RIND, IMMATURE (UNII: ZPS7Q5U53K) (JUGLANS REGIA

FRUIT RIND, IMMATURE - UNII:ZPS7Q5U53K)

JUGLANS REGIA FRUIT

RIND, IMMATURE

30 [hp_X]

in 1 g

VINCA MINO R (UNII: WGM46 PQF0 2) (VINCA MINOR - UNII:WGM46 PQF0 2)

VINCA MINOR

30 [hp_X]

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PHYTO LACCA AMERICANA FRUIT (UNII: WE6 36 6 149 9 )

O LIVE O IL (UNII: 6 UYK2W1W1E)

AVO CADO O IL (UNII: 6 VNO72PFC1)

MACADAMIA O IL (UNII: 5156 10 SU8 C)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PO LYETHYLENE GLYCO L 150 0 (UNII: 1212Z7S33A)

PEG-8 DIMETHICO NE (UNII: GIA7T76 4OD)

PO LYETHYLENE GLYCO L 7 0 0 (UNII: 76 26 78 AC5R)

KUKUI NUT O IL (UNII: TP11QR7B8 R)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

LARREA TRIDENTATA TO P (UNII: PK0 TXD0 49 P)

PHYTO LACCA AMERICANA RO O T (UNII: 11E6 VI8 VEG)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

HYPERICUM PERFO RATUM (UNII: XK4IUX8 MNB)

SALIX ALBA BARK (UNII: 20 5MXS71H7)

SANGUINARIA CANADENSIS RO O T (UNII: N9 28 8 CD50 8 )

CO MFREY LEAF (UNII: DG4F8 T8 39 X)

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

AZADIRACHTA INDICA LEAF (UNII: HKY9 1578 0 T)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

O REGANO (UNII: 0 E5AT8 T16 U)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:438 46 -0 0 0 8 -2

1 in 1 CARTON

0 8 /11/20 16

1

NDC:438 46 -0 0 0 8 -1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Peaceful Mountain, Inc.

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 3/19 /20 13

Labeler -

Peaceful Mountain, Inc. (078430707)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(438 46 -0 0 0 8 ) , api manufacture(438 46 -0 0 0 8 ) , label(438 46 -0 0 0 8 ) ,

pa c k(438 46 -0 0 0 8 )

Revised: 6/2020

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