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

ECZEMA RESCUE (CARBOLICUM ACIDUM, FAGOPYRUM ESCULENTUM, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, JUGLANS REGIA, VINCA MINOR) GEL [PEACEFUL MOUNTAIN, INC.]
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NDC	43846-0012-1
Set ID	67bcfb13-4a75-41fb-bb09-0217c766d7e3
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
USES:

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

When using this product

• Do not get into eyes

Stop use and ask a doctor if

• Condition worsens

• Symptoms last more than 7 days

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.
USES:

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 Mon-Fri 8a.m-5 p.m. CST

www.peacefulmountain.com
PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

eczema rescue

homeopathic gel

Temporary

soothing relief

for symptoms of

eczema: rash,

burning, itching,

chapped, dry, or

cracked skin

Net wt. 1 oz. (28 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43846-0012
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 LEAF (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:43846-0012-1	28 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/24/2015

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43846-0012) , api manufacture(43846-0012) , label(43846-0012) , pack(43846-0012)

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Medic

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

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