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

ECZEMA RESCUE (CABOLICUM ACIDUM, FAGOPYRUM ESCULENTUM, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, JUGLANS REGIA, VINCA MINOR) LOTION [PEACEFUL MOUNTAIN, INC.]
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NDC	43846-0019-1
Set ID	d85ed812-f3f1-4a1d-820b-2d3271b26f65
Category	HUMAN OTC DRUG LABEL
Packager	Peaceful Mountain, Inc.
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENTS:

CABOLICUM ACIDUM 30X, FAGOPYRUM ESCULENTUM 30X, HYDRASTIS CANADENSIS 30X, HYDROCOTYLE ASIATICA 30X, JUGLANS REGIA 30X, VINCA MINOR 30X
SUGGESTED USE:

Helps temporarily relieve minor symptoms of eczema such as irritated, red, burning, itching, dry, rough, scaly, chapped, cracked skin, rashes, urticaria (hives), eruptions, eczema, psoriasis, generally unhealthy skin.
WARNINGS:

For external use only.

Avoid contact with eyes.

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. Consult a physician for use in children under 12 years of age.
SUGGESTED USE:

Helps temporarily relieve minor symptoms of eczema such as irritated, red, burning, itching, dry, rough, scaly, chapped, cracked skin, rashes, urticaria (hives), eruptions, eczema, psoriasis, generally unhealthy skin.
INACTIVE INGREDIENTS:

ALOE VERA 10X CONCENTRATE, ARNICA MONTANA (FLOWER), AVOCADO OIL, SANGUINARIA CANADENSIS (ROOT), CALENDULA OFFICINALIS (FLOWER), CARBOMER (ULTREZ 21), LARREA TRIDENTATA (LEAF), SYMPHYTUM OFFICINALE (LEAF), EDETATE DISODIUM (EDTA), KUKUI NUT OIL, MACADAMIA NUT OIL, NATURAL PLANT EXTRACT (ORIGANOX WS), AZADIRACHTA INDICA (LEAF), OLIVE OIL, PEG-33, PEG-8 DIMETHICONE, PEG-14 (SILSENSE COPOLYOL-1 SILICONE), PHENOXYETHANOL, CAPRYLYL GLYCOL, SORBIC ACID (OPTIPHEN PLUS) PHYTOLACCA AMERICANA (BERRY), PHYTOLACCA AMERICANA (ROOT), POLYSORBATE 20 [TWEEN 20], POTASSIUM SORBATE, PURIFIED WATER, SODIUM HYDROXIDE (SOLUTION), HYPERICUM PERFORATUM (AERIAL PARTS), VITAMIN C (POWDER)[ASCORBIC ACID], VITAMIN E (DERIVED FROM SOY BEAN), SALIX ALBA (BARK)
QUESTIONS:

Dist. by:

Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com
PACKAGE LABEL DISPLAY:

Peaceful Mountain

Eczema Rescue

Homeopathic Lotion

Net wt. 4 lbs. (64 oz.) (1.8 kg)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43846-0019
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
AVOCADO OIL (UNII: 6VNO72PFC1)
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
LARREA TRIDENTATA TOP (UNII: PK0TXD049P)
COMFREY LEAF (UNII: DG4F8T839X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
KUKUI NUT OIL (UNII: TP11QR7B8R)
MACADAMIA OIL (UNII: 515610SU8C)
OREGANO (UNII: 0E5AT8T16U)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
OLIVE OIL (UNII: 6UYK2W1W1E)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SALIX ALBA BARK (UNII: 205MXS71H7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43846-0019-1	1814 g in 1 JUG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/15/2014

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43846-0019) , api manufacture(43846-0019) , label(43846-0019) , pack(43846-0019)

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Medic

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

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