MedPath

Eczema Rescue

Drug Facts:

Approved
Approval ID

2c2f24ad-f4bd-468b-9c84-290dcbf2ba1a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Peaceful Mountain, Inc.

DUNS: 078430707

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Carbolicum Acidum, Fagopyrum Esculentum, Hydrastis Canadensis, Hydrocotyle Asiatica, Juglans Regia, Vinca Minor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43846-0017
Product Classification
G
Generic Name
Carbolicum Acidum, Fagopyrum Esculentum, Hydrastis Canadensis, Hydrocotyle Asiatica, Juglans Regia, Vinca Minor
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (37)

PHENOLActive
Quantity: 30 [hp_X] in 1 g
Code: 339NCG44TV
Classification: ACTIB
FAGOPYRUM ESCULENTUMActive
Quantity: 30 [hp_X] in 1 g
Code: B10M69172N
Classification: ACTIB
GOLDENSEALActive
Quantity: 30 [hp_X] in 1 g
Code: ZW3Z11D0JV
Classification: ACTIB
CENTELLA ASIATICAActive
Quantity: 30 [hp_X] in 1 g
Code: 7M867G6T1U
Classification: ACTIB
JUGLANS REGIA LEAFActive
Quantity: 30 [hp_X] in 1 g
Code: 85HKB87105
Classification: ACTIB
JUGLANS REGIA FRUIT RIND, IMMATUREActive
Quantity: 30 [hp_X] in 1 g
Code: ZPS7Q5U53K
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHYTOLACCA AMERICANA FRUITInactive
Code: WE63661499
Classification: IACT
OLIVE OILInactive
Code: 6UYK2W1W1E
Classification: IACT
AVOCADO OILInactive
Code: 6VNO72PFC1
Classification: IACT
MACADAMIA OILInactive
Code: 515610SU8C
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)Inactive
Code: 59TL3WG5CO
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
POLYETHYLENE GLYCOL 1500Inactive
Code: 1212Z7S33A
Classification: IACT
PEG-8 DIMETHICONEInactive
Code: GIA7T764OD
Classification: IACT
POLYETHYLENE GLYCOL 700Inactive
Code: 762678AC5R
Classification: IACT
KUKUI NUT OILInactive
Code: TP11QR7B8R
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
LARREA TRIDENTATA LEAFInactive
Code: PK0TXD049P
Classification: IACT
PHYTOLACCA AMERICANA ROOTInactive
Code: 11E6VI8VEG
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZ
Classification: IACT
ST. JOHN'S WORTInactive
Code: UFH8805FKA
Classification: IACT
SALIX ALBA BARKInactive
Code: 205MXS71H7
Classification: IACT
SANGUINARIA CANADENSIS ROOTInactive
Code: N9288CD508
Classification: IACT
COMFREY LEAFInactive
Code: DG4F8T839X
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
AZADIRACHTA INDICA LEAFInactive
Code: HKY915780T
Classification: IACT
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ORIGANUM VULGARE SUBSP. HIRTUM FLOWERInactive
Code: 3799SP11NY
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
VINCA MINORActive
Quantity: 30 [hp_X] in 1 g
Code: WGM46PQF02
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/6/2016

PACKAGE LABEL DISPLAY:

peaceful mountain
THE HEIGHT OF HEALTH

eczema rescue

homeopathic lotion

formulated in boulder, co
Net wt. 0.25 oz, (7 g)

Eczema Rescue

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/7/2016

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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/7/2016

Dist by:

Peaceful Mountain, Inc.

Woodbine, IA 51579 883-303-3388

www.peacefulmountain.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/7/2016

ACTIVE INGREDIENTS:

Carbolicum Acidum 30X, Fagopyrum Esculentum 30X, Hydrastis Canadensis 30X, Hydrocotyle Asiatica 30X, Juglans Regia 30X, Vinca Minor 30X

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/7/2016

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 SECTION

LOINC: 34071-1Updated: 7/7/2016

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/7/2016

DIRECTIONS:

Apply at least 3 times daily over the affected area.

Children under 12 years of age: Consult a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/7/2016

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/7/2016

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.

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