FDA.reportPublic FDA data

Trauma plus Gel

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:20:17

Label at a glance#

ProductTrauma plus Gel
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, HYPERICUM PERFORATUM, COMFREY ROOT, BELLIS PERENNIS, LEDUM PALUSTRE TWIG, SULFURIC ACID, CALCIUM FLUORIDE, FERROSOFERRIC PHOSPHATE, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SODIUM SULFATE
Label structure9 sections

Dosage and administration

Apply small amount every 10 minutes for 3 doses immediately after injury, then 2 to 3 times daily. For topical use only.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis 1X, Arnica Montana 1X, 30C, Hypericum Perforatum 1X, 30C, Symphytum Officinale 3X, Bellis Perennis 12X, Ledum Palustre 12X, Sulphuricum Acidum 12X, Calcarea Fluorica 30X, Ferrum phosphoricum 30X, Rhus Tox 30X, Ruta Graveolens 30X, Natrum Sulphuricum 30C  

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all body injuries**

**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 an adverse reaction occurs, discontinue use.

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 use if tamper evident seal is broken or missing.

Store in a cool, dry place.

Do not expose product to extreme temperatures.

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

Apply small amount every 10 minutes for 3 doses immediately after injury, then 2 to 3 times daily. For topical use only.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of bumps, bruises, abrasions, strains, sprains, fractures, stiffness; for all body injuries**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Alcohol, Biosaccharide Gum-1 (natural moisturizer derived from sorbitol) Carbomer (polymer), Glycerin, NaPCA (natural hydration factor), Sodium Hydroxymethlglycinate (preservative derived from amino acid glycine), Tromethamine (amine based organic buffer), Water

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

TRAUMA+GEL

Net wt. 2 oz. (57 g)

Trauma Plus GelTrauma Plus Gel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0124-12021-12-29C16284748780-19d75b9d0-f808-f424-e053-dadaa90a57ceDRUG FACTS
44911-0124-12020-01-31C16284748780-19d75b9d0-f808-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
BELLIS PERENNISACTIVE INGREDIENT2HU33I03UY1
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ1
COMFREY ROOTACTIVE INGREDIENTM9VVZ08EKQ1
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F71
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNB1
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0P1
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587S1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
SULFURIC ACIDACTIVE INGREDIENTO40UQP6WCF1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A1
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
BELLIS PERENNISACTIVE MOIETY2HU33I03UY1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ1
COMFREY ROOTACTIVE MOIETYM9VVZ08EKQ1
FERROSOFERRIC PHOSPHATEACTIVE MOIETY91GQH8I5F71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNB1
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0P1
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587S1
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7501
SULFURIC ACIDACTIVE MOIETYO40UQP6WCF1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
BIOSACCHARIDE GUM-1INACTIVE INGREDIENTBB4PU4V09H1
CARBOMER INTERPOLYMER TYPE A (55000 CPS)INACTIVE INGREDIENT59TL3WG5CO1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
SODIUM HYDROXYMETHYLGLYCINATEINACTIVE INGREDIENTDIG6BWZ9XT1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A21
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2V1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-012444911-0124-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ARNICA MONTANAO80TY208ZWACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
COMFREY ROOTM9VVZ08EKQACTIB
BELLIS PERENNIS2HU33I03UYACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
SULFURIC ACIDO40UQP6WCFACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
SODIUM SULFATE0YPR65R21JACTIB
ALCOHOL3K9958V90MIACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
GLYCERINPDC6A3C0OXIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
SODIUM HYDROXYMETHYLGLYCINATEDIG6BWZ9XTIACT
TROMETHAMINE023C2WHX2VIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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 3 · 163 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / RECTAL0.12 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSUSPENSION / ENDOTRACHEAL2.42 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION, GEL FORMING / DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii candidate
TROMETHAMINETROMETHAMINE023C2WHX2VSUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VINJECTION / INTRA-ARTERIAL562 mgExact identifier — unii candidate
28 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VINJECTION, SOLUTION / INTRAVENOUS300 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / ORAL1.21 mg/1mlExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VINJECTION, SOLUTION / INTRAMUSCULAR1.21 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / RESPIRATORY (INHALATION)0.01 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VINJECTION / INTRAVENOUS1134 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / INTRAVASCULAR0.12 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.8 %w/wExact identifier — unii candidate
28 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
a5ad1b43-abb8-4cdb-8278-563504b5964fa0bbfefb-1a1d-4eb8-9c68-3ab4879440f92021-12-29WarningsExact identifier
spl id: a5ad1b43-abb8-4cdb-8278-563504b5964f
spl set id: a0bbfefb-1a1d-4eb8-9c68-3ab4879440f9

Reported adverse events (FAERS/openFDA)#

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