Eczema Rescue (Carbolicum Acidum, Fagopyrum Esculentum, Hydrastis Canadensis, Hydrocotyle Asiatica, Juglans Regia, Vinca Minor) Lotion [Peaceful Mountain, Inc.] -

ECZEMA RESCUE (CARBOLICUM ACIDUM, FAGOPYRUM ESCULENTUM, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, JUGLANS REGIA, VINCA MINOR) LOTION [PEACEFUL MOUNTAIN, INC.]
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NDC	43846-0017-1
Set ID	2c2f24ad-f4bd-468b-9c84-290dcbf2ba1a
Category	HUMAN OTC DRUG LABEL
Packager	Peaceful Mountain, Inc.
Generic Name
Product Class
Product Number
Application Number

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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.**

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

For external use only.

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

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

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
DIRECTIONS:

Apply at least 3 times daily over the 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 Gratissima), Macadamia Nut Oil (Macadamia Integrifolia), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10 Alkyl 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), Arnica Montana Flower, St. Johns Wort Aerial Parts (Hypericum Perforatum), White Willow Bark (Salix Alba), Bloodroot Root (Sanguinaria Canadensis), Comfrey Leaf (Symphytum Officinale), Ascorbic Acid, Neem Leaf (Azadirachta Indica), Calendula Officinalis Flower, Vitamin E Oil, 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 Center right away.
INDICATIONS:

May temporarily relieve minor symptoms of eczema.**

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

Dist by:

Peaceful Mountain, Inc.

Woodbine, IA 51579 883-303-3388

www.peacefulmountain.com
PACKAGE LABEL DISPLAY:

peaceful mountain
THE HEIGHT OF HEALTH

eczema rescue

homeopathic lotion

formulated in boulder, co
Net wt. 0.25 oz, (7 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:43846-0017
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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 LEAF (UNII: PK0TXD049P)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ST. JOHN'S WORT (UNII: UFH8805FKA)
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)
ORIGANUM VULGARE SUBSP. HIRTUM FLOWER (UNII: 3799SP11NY)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43846-0017-1	7 g in 1 PACKET; Type 0: Not a Combination Product	07/06/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/14/2012

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43846-0017) , api manufacture(43846-0017) , label(43846-0017) , pack(43846-0017)

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Medic

ECZEMA RESCUE (CARBOLICUM ACIDUM, FAGOPYRUM ESCULENTUM, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, JUGLANS REGIA, VINCA MINOR) LOTION [PEACEFUL MOUNTAIN, INC.]

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