FDA.reportPublic FDA data

Pain

Manufacturer
Peaceful Mountain, Inc. | Apotheca Company
Effective date
2021-12-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:22:23

Label at a glance#

ProductPain
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, CROTON TIGLIUM SEED, SODIUM CHLORIDE, PLANTAGO MAJOR, TOXICODENDRON PUBESCENS LEAF, SMILAX ORNATA ROOT
Label structure9 sections

Dosage and administration

Adults and children spray liberally on affected area as needed. If symptoms persist, consult your health care professional. 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, Sarsaparilla (Smilax Regelii) 30X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve minor aches and pains.**

**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

Adults and children spray liberally on affected area as needed. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve minor aches and pains.**

**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, Arnica Flower*, Chaparral Leaf*, Comfrey Leaf*, Dragon's Blood Croton Sap, English Lavender Buds*, Ionic Colloidal Silver, Lemon Balm Leaf*, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Poke Berries*, Poke Root*, Potassium Sorbate, Purified Water, Sodium Bicarbonate, St. John's Wort Aerial Parts*, Tocopherols (soy), Vitamin C, Whey Protein Concentrate (Milk), White Willow Bark* and Yarrow Flower*.
*Extract

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579   888-303-3388

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEACEFUL MOUNTAIN

Pain Spray

HOMEOPATHIC

1 FL OZ (30 ml)

Pain SprayPain Spray

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43846-0053-12021-12-16C16284748780-19d75b9d0-29e3-f424-e053-dadaa90a57ceDrug Facts:
43846-0053-12020-01-31C16284748780-19d75b9d0-29e3-f424-e053-dadaa90a57ceDrug Facts:

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43846-005343846-0053-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CROTON TIGLIUM SEED0HK2GZK66EACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
PLANTAGO MAJORW2469WNO6UACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SMILAX ORNATA ROOT2H1576D5WGACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
LARREA TRIDENTATA LEAFPK0TXD049PIACT
COMFREY LEAFDG4F8T839XIACT
CROTON LECHLERI RESINGGG6W25C63IACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
SILVER3M4G523W1GIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
POLYETHYLENE GLYCOL 700762678AC5RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBIC ACIDX045WJ989BIACT
PHYTOLACCA AMERICANA FRUITWE63661499IACT
PHYTOLACCA AMERICANA ROOT11E6VI8VEGIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
HYPERICUM PERFORATUMXK4IUX8MNBIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
WHEY8617Z5FMF6IACT
SALIX ALBA BARK205MXS71H7IACT
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAIACT

Source Document#

Source XML

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
6120b5a8-787e-4a48-90b3-e9380aebd6c463e73e6d-46ca-42eb-8111-28395e21d5b82021-12-16WarningsExact identifier
spl id: 6120b5a8-787e-4a48-90b3-e9380aebd6c4
spl set id: 63e73e6d-46ca-42eb-8111-28395e21d5b8

Reported adverse events (FAERS/openFDA)#

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