Skin Irritant and Healing Support

Manufacturer
Peaceful Mountain, Inc. | Apotheca Company
Effective date
2021-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:22:42

Label at a glance#

ProductSkin Irritant and Healing Support
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, CROTON TIGLIUM SEED, SODIUM CHLORIDE, PLANTAGO MAJOR, TOXICODENDRON PUBESCENS LEAF, SARSAPARILLA
Label structure9 sections

Dosage and administration

Spray liberally on affected area as needed. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

CALENDULA OFFICINALIS 12X, CROTON TIGLIUM 30X, NATRUM MURIATICUM 30X, PLANTAGO MAJOR 30X, RHUS TOX 30X, SARSAPRILLA (SMILAX REGELII) 30X

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve pain due to inflammation caused by but not limited to the following: rashes, chafing, dryness.**

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

WARNINGS:

WARNINGS SECTION

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.

Do not get into eyes.

If symptoms persist, consult a doctor.

Do not use if tamper evident seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Spray liberally on affected area as needed. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve pain due to inflammation caused by but not limited to the following: rashes, chafing, dryness.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS LEAF JUICE (ALOE VERA 10X CONCENTRATE), ARNICA MONTANA (FLOWER)*, LARREA TRIDENTATA (LEAF)*, SYMPHYTUM OFFICINALE (LEAF)*, CROTON LECHLERI (SAP), INSTANTIZED SOLUBLE EGGSHELL MEMBRANE + (BIOVADERM BRAND WITH 1% SUNFLOWER LECITHIN), LAVANDULA ANGUSTIFOLIA (BUDS)*, IONIC COLLOIDAL SILVER, MELISSA OFFICINALIS (LEAF)*, [PEG-33, PEG-8 DIMETHICONE, PEG-14 (SILSENSE COPOLYOL-1 SILICONE)], [PHENOXYETHANOL, CAPRYLYL GLYCOL, SORBIC ACID (OPTIPHEN-PLUS)], PHYTOLACCA AMERICANA (BERRIES)*, PHYTOLACCA AMERICANA (ROOT)*, POTASSIUM SORBATE, PURIFIED WATER, SODIUM BICARBONATE, HYPERICUM PERFORATUM (AERIAL PARTS)*, TOCOPHEROL [VITAMIN E OIL](DERIVED FROM SOY BEAN), VITAMIN C POWDER (ASCORBIC ACID), WHEY PROTEIN CONCENTRATE, SALIX ALBA (BARK)*, ACHILLEA MILLEFOLIUM (FLOWER)*

*EXTRACT

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

peaceful mountain

THE HEIGHT OF HEALTH

skin irritant & healing support

homeopathic spray

1 fl. oz. (30 mL)

Skin Irritant and Healing SupportSkin Irritant and Healing Support

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43846-0046-12021-12-14C16284748780-19d75b9d0-b182-f424-e053-dadaa90a57ceDRUG FACTS:
43846-0046-12020-01-31C16284748780-19d75b9d0-b182-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ2
CROTON TIGLIUM SEEDACTIVE INGREDIENT0HK2GZK66E2
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6U2
SARSAPARILLAACTIVE INGREDIENT2H1576D5WG2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X2
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A2
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ2
CHLORIDE IONACTIVE MOIETYQ32ZN486982
CROTON TIGLIUM SEEDACTIVE MOIETY0HK2GZK66E2
PLANTAGO MAJORACTIVE MOIETYW2469WNO6U2
SARSAPARILLAACTIVE MOIETY2H1576D5WG2
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ12
ACHILLEA MILLEFOLIUM FLOWERINACTIVE INGREDIENTYQR8R0SQEA2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZ2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839X2
CROTON LECHLERI RESININACTIVE INGREDIENTGGG6W25C632
EGG SHELL MEMBRANEINACTIVE INGREDIENTN7QBR4212V2
HYPERICUM PERFORATUMINACTIVE INGREDIENTXK4IUX8MNB2
LARREA TRIDENTATA TOPINACTIVE INGREDIENTPK0TXD049P2
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4M2
LECITHIN, SUNFLOWERINACTIVE INGREDIENT834K0WOS5G2
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE92192
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764OD2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
PHYTOLACCA AMERICANA FRUITINACTIVE INGREDIENTWE636614992
PHYTOLACCA AMERICANA ROOTINACTIVE INGREDIENT11E6VI8VEG2
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33A2
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5R2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ42
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H72
SILVERINACTIVE INGREDIENT3M4G523W1G2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B2
WATERINACTIVE INGREDIENT059QF0KO0R2
WHEYINACTIVE INGREDIENT8617Z5FMF62

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43846-004643846-0046-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 119 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBIC ACIDSORBIC ACIDX045WJ989BSUSPENSION / ORAL40 mgExact identifier — unii candidate
19 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / RESPIRATORY (INHALATION)0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BEMULSION / OPHTHALMIC1 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOLOZENGE / ORAL100 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33ATABLET / ORAL1.2 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET / ORAL80 mgExact identifier — unii candidate
25 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / ORAL10 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / ORAL360 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS160 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33AGEL / DENTAL5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INFILTRATION0.2 %w/vExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / ORAL600 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INTRAVENOUS4 mgExact identifier — unii candidate
25 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4LOTION / TOPICAL0.2 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii candidate
19 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
25 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION/ DROPS / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
34 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCAPSULE, DELAYED RELEASE / ORAL12 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSYRUP / ORAL200 mgExact identifier — unii candidate
25 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / SUBLINGUAL0.16 mgExact identifier — unii candidate
19 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2 mgExact identifier — unii candidate
25 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii candidate
19 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
34 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BLOTION / TOPICAL4 mgExact identifier — unii candidate
19 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / RECTAL6.67 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii candidate
19 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUPPOSITORY / RECTAL3 mgExact identifier — unii candidate
25 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii candidate
34 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33ASOLUTION / TOPICAL29.7 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOCAPSULE, DELAYED RELEASE PELLETS / ORAL4 mgExact identifier — unii candidate
34 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVENOUS812 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / SUBLINGUAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2e6905c8-6208-4e01-a23c-89605ac7818d30de43a9-e4dc-406c-884b-628cf0f05ddb2021-12-14WarningsExact identifier
spl id: 2e6905c8-6208-4e01-a23c-89605ac7818d
spl set id: 30de43a9-e4dc-406c-884b-628cf0f05ddb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.