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

Eczema Rescue by

Drug Labeling and Warnings

Eczema Rescue by is a Homeopathic medication manufactured, distributed, or labeled by Peaceful Mountain, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

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 such as:  Irritated  Red  Burning  Itching  Dry  Rough  Scaly  Chapped  Cracked skin  Rashes  Urticaria (hives)  Eruptions   Skin Inflammation Generally unhealthy skin.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

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 right away. 

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

DIRECTIONS:

Apply at least 3 times daily over affected area.  

Children under 12 years of age: Consult a doctor.

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, 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

KEEP OUT OF REACH OF CHILDREN:

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

INDICATIONS:

May temporarily relieve minor symptoms of eczema such as: Irritated Red Burning Itching Dry Rough Scaly Chapped Cracked skin Rashes Urticaria (hives) Eruptions Skin Inflammation Generally unhealthy skin.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

QUESTIONS:

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

Dist. by Peaceful Mountain, Inc., Woodbine, IA 51579    www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

eczema rescue

homeopathic

lotion

Temporary soothing relief for symptoms of eczema: rash, burning, itching, chapped, dry, or cracked skin**

peaceful mountain

THE HEIGHT OF HEALTH

Net wt. 1 oz. (28 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	30 [hp_X]  in 1 g
FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N)	FAGOPYRUM ESCULENTUM	30 [hp_X]  in 1 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	30 [hp_X]  in 1 g
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U)	CENTELLA ASIATICA	30 [hp_X]  in 1 g
JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105)	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 MINOR (UNII: WGM46PQF02) (VINCA MINOR - UNII:WGM46PQF02)	VINCA MINOR	30 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)
OLIVE OIL (UNII: 6UYK2W1W1E)
AVOCADO OIL (UNII: 6VNO72PFC1)
MACADAMIA OIL (UNII: 515610SU8C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
KUKUI NUT OIL (UNII: TP11QR7B8R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LARREA TRIDENTATA TOP (UNII: PK0TXD049P)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
SALIX ALBA BARK (UNII: 205MXS71H7)
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508)
COMFREY LEAF (UNII: DG4F8T839X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OREGANO (UNII: 0E5AT8T16U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0008-2	1 in 1 CARTON	08/11/2016
1	NDC: 43846-0008-1	28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/19/2013

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0008) , api manufacture(43846-0008) , label(43846-0008) , pack(43846-0008)