FDA.reportPublic FDA data

Injure Gel

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:19:27

Label at a glance#

ProductInjure Gel
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, COMFREY ROOT, BELLIS PERENNIS WHOLE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SULFURIC ACID, CALCIUM FLUORIDE, FERROSOFERRIC PHOSPHATE, TOXICODENDRON PUBESCENS LEAF, ARNICA MONTANA WHOLE, HYPERICUM PERFORATUM WHOLE, SODIUM SULFATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Arnica Montana4X, 30C, Calendula Officinalis 4X, Hypericum Perf 4X, 30C, Symphytum Off 6X, Bellis Per 12X, Ledum Palustre 12X, Sulphuricum Ac 12X, Calc Fluor 30X, Ferrum Phos 30X, Rhus Tox 30X, Nat Sulphuricum 30C

INDICATIONS & USAGE SECTION

USES: Temporarily relieves soreness and bruised feelings.**

OTC - PURPOSE SECTION

USES: Temporarily relieves soreness and bruised feelings.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Apply small amount every 10 minutes for 3 doses immediately after injury. Then 2-3 times daily.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • FOR TOPICAL USE ONLY
  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Carbomer 980, Ehtanol Alcohol, Glycerin USP, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxide

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:43406-0707-5

Injure Gel

HOMEOPATHIC

 2 oz (56.7 g)

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0707-5Injure Gel56.7 g in 1 TUBEGEL56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0707INJURE GEL (ARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERF, SYMPHYTUM OFF, BELLIS PER, LEDUM PALUSTRE, SULPHURICUM AC, CALC FLUOR, FERRUM PHOS, RHUS TOX, NAT SULPHURICUM) GEL [NATURAL CREATIONS, INC]1Current NDC, Legacy NDC, 1 package rows20230111_8893c906-0dab-44ef-956b-b5427d4dbf7f.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-070743406-0707-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
COMFREY ROOTM9VVZ08EKQACTIB
BELLIS PERENNIS WHOLE2HU33I03UYACTIB
RHODODENDRON TOMENTOSUM LEAFY TWIG877L01IZ0PACTIB
SULFURIC ACIDO40UQP6WCFACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ARNICA MONTANA WHOLEO80TY208ZWACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
SODIUM SULFATE0YPR65R21JACTIB
CARBOMER 9804Q93RCW27EIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA WHOLEKIZ4X2EHYXIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
Injure GelARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERF, SYMPHYTUM OFF, BELLIS PER, LEDUM PALUSTRE, SULPHURICUM AC, CALC FLUOR, FERRUM PHOS, RHUS TOX, NAT SULPHURICUMNatural Creations, Inc8893c906-0dab-44ef-956b-b5427d4dbf7f2018-12-21WarningsExact identifier
ndc (package): 43406-0707-5
ndc (product): 43406-0707
ndc11 (package): 43406070705
spl id: 4919a13d-e595-4bb8-bc30-7ebf9cc74e95
spl set id: 8893c906-0dab-44ef-956b-b5427d4dbf7f

Reported adverse events (FAERS/openFDA)#

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