FDA.reportPublic FDA data

Dermapain Relief

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2022-05-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:01:09

Label at a glance#

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

Dosage and administration

Adults and children shake well and spray liberally on affected area as needed. If symptoms persist for more than 7 days, 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

(in each spray): 0.21% of 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 shooting pain, itching, burning, and sensitivity to touch, with or after eruptions and blisters.**

**Claims based on traditional homeopathic practice, not accepted medical evidence, Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

For exteranl use only. If pregnant or breastfeeding, 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.

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

SHAKE WELL

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 shake well and spray liberally on affected area as needed. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve shooting pain, itching, burning, and sensitivity to touch, with or after eruptions and blisters.**

**Claims based on traditional homeopathic practice, not accepted medical evidence, Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc., 201 Apple Blvd.
Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

DERMAPAIN

RELIEF

Topical Spray

1 fl. oz. (30 ml)

Dermapain ReliefDermapain Relief

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-064344911-0643-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CROTON TIGLIUM SEED0HK2GZK66EACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
PLANTAGO MAJOR WHOLEW2469WNO6UACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SMILAX ORNATA ROOT2H1576D5WGACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
LARREA TRIDENTATA LEAFPK0TXD049PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COMFREY LEAFDG4F8T839XIACT
CROTON LECHLERI RESINGGG6W25C63IACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
ALCOHOL3K9958V90MIACT
SILVER3M4G523W1GIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
POLYETHYLENE GLYCOL 700762678AC5RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBIC ACIDX045WJ989BIACT
PHYTOLACCA AMERICANA FRUITWE63661499IACT
PHYTOLACCA AMERICANA ROOT11E6VI8VEGIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ST. JOHN'S WORTUFH8805FKAIACT
.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
70cc5cd8-e11f-4216-bd20-937daa3dc9fb7218f2a0-3650-4c79-998c-3cb3ffbf89f32022-05-17WarningsExact identifier
spl id: 70cc5cd8-e11f-4216-bd20-937daa3dc9fb
spl set id: 7218f2a0-3650-4c79-998c-3cb3ffbf89f3

Reported adverse events (FAERS/openFDA)#

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