ECZEMA RESCUE- cabolicum 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.

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DRUG FACTS:

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)

Eczema Rescue 5 gal

ECZEMA RESCUE 
cabolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL30 [hp_X]  in 1 g
FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM30 [hp_X]  in 1 g
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL30 [hp_X]  in 1 g
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA30 [hp_X]  in 1 g
JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105) JUGLANS REGIA LEAF30 [hp_X]  in 1 g
JUGLANS REGIA FRUIT RIND, IMMATURE (UNII: ZPS7Q5U53K) (JUGLANS REGIA FRUIT RIND, IMMATURE - UNII:ZPS7Q5U53K) JUGLANS REGIA FRUIT RIND, IMMATURE30 [hp_X]  in 1 g
VINCA MINOR (UNII: WGM46PQF02) (VINCA MINOR - UNII:WGM46PQF02) VINCA MINOR30 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0019-11814 g in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/15/2014
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0019) , api manufacture(43846-0019) , label(43846-0019) , pack(43846-0019)

Revised: 12/2014
Document Id: 0ea9984d-0289-43b9-95b2-844e946048cc
Set id: d85ed812-f3f1-4a1d-820b-2d3271b26f65
Version: 1
Effective Time: 20141215
 
Peaceful Mountain, Inc.