Soothing First Aid Cream

Manufacturer
Homeo Health, Inc. | OHM PHARMA INC.
Effective date
2019-09-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:11:27

Label at a glance#

ProductSoothing First Aid Cream
Active ingredientATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, LYTTA VESICATORIA, CAUSTICUM, HYPERICUM PERFORATUM, DELPHINIUM STAPHISAGRIA SEED
Label structure9 sections

Indications and uses

Uses: Temporarily relieves pain due to minor skin injuries such as scrapes and cuts. Supports healthy recovery.

Dosage and administration

Directions: For topical use only. Apply a small amount to affected area 3 times a day or as directed by a health care professional.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (HPUS*):

Purpose:

Belladonna 4X

Relieves Sunburn Pain

Calendula Officinalis 1X

Relieves Pain

Cantharis 5X

Relieves Burning Pain

Causticum 6X

Relieves Chapping, Raw Pain

Hypericum Perforatum 1X

Relieves Pain

Staphysagria 5X

Relieves Sharp Pains

USES

INDICATIONS & USAGE SECTION

Uses: Temporarily relieves pain due to minor skin injuries such as scrapes and cuts. Supports healthy recovery.

WARNINGS

WARNINGS SECTION

Warnings:

  • For topical use only
  • If pregnant or breast-feeding, ask a health care professional before use
  • Keep out of the reach of children
  • If symptoms persist or worsen, discontinue use and contact a health care professional
  • In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions: For topical use only. Apply a small amount to affected area 3 times a day or as directed by a health care professional.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other Information: Do not use if cap seal is broken or missing. Store at room temperature.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive Ingredients*: Borax, Caprylyl Glycol, Coconut Oil, Emulsifying Wax NF, Organic Sunflower Oil, Phenoxyethanol, Purified Water, Vitamin E Oil.

* listed alphabetically

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Questions or Comments?

Homeo-Health, Inc.

Ph: (713) 366 8700

SPL UNCLASSIFIED SECTION

Mfg By:

OHM Pharma, Inc.

Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 60914-001-00

NDC: 60914-001-01

NDC: 60914-001-02

HOMEO-HEALTH INC.

Homeopathic Remedies for Health

SOOTHING FIRST AID CREAM

Cuts, Burns, Scrapes

Soothing * Healing

TOPICAL HOMEOPATHIC

Net Wt: 0.49 oz (14 g)

Net Wt: 1.75 oz (50 g)

Net Wt: 3.35 oz (95 g)

Soothing First Aid Cream 14gSoothing First Aid Cream 14gSoothing First Aid Cream 50g front labelSoothing First Aid Cream 50g front label

Soothing First Aid Cream 50g back labelSoothing First Aid Cream 50g back label

Soothing First Aid Cream 95gSoothing First Aid Cream 95g

OTC - PURPOSE SECTION

Cuts, Burns, Scrapes

Soothing * Healing

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60914-001-002021-01-29C16284748780-1ba0f9c33-51b9-a910-e053-dadaa90a0b85Soothing First Aid Cream
60914-001-012021-01-29C16284748780-1ba0f9c33-51b9-a910-e053-dadaa90a0b85Soothing First Aid Cream
60914-001-022021-01-29C16284748780-1ba0f9c33-51b9-a910-e053-dadaa90a0b85Soothing First Aid Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60914-001-00Soothing First Aid Cream14 g in 1 TUBECREAM143
60914-001-01Soothing First Aid Cream50 g in 1 TUBECREAM503
60914-001-02Soothing First Aid Cream95 g in 1 TUBECREAM953

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60914-001SOOTHING FIRST AID CREAM CREAM [HOMEO HEALTH, INC.]3Legacy NDC, 3 package rows20190906_035ebfd1-4673-234f-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H2
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ2
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFU2
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JV2
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNB2
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BT2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H2
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ2
CAUSTICUMACTIVE MOIETYDD5FO1WKFU2
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JV2
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNB2
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BT2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ12
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7L2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QO2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60914-00160914-001-02, 60914-001-01, 60914-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 1 · 41 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOCREAM / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LTABLET / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOLUTION / TOPICAL15.5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MTABLET, COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LAEROSOL, FOAM / TOPICAL23.6 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOEMULSION / OPHTHALMIC0.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / VAGINAL0.03 mgExact identifier — unii candidate
13 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LCAPSULE, LIQUID FILLED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / ORAL125 mgExact identifier — unii candidate
13 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / RECTAL0.05 mg/mgExact identifier — unii candidate
13 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSHAMPOO / TOPICAL14.55 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / TOPICAL2.85 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSUSPENSION/ DROPS / OPHTHALMIC0.03 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MEMULSION / ORAL20 mg/1mlExact identifier — unii candidate
13 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION / OPHTHALMIC2 mgExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
13 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LOINTMENT / TOPICAL14.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MOINTMENT / TOPICAL2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION / AURICULAR (OTIC)0.3 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / VAGINAL200 mgExact identifier — unii candidate
13 equally ranked IID candidates
COCONUT OILCOCONUT OILQ9L0O73W7LSOAP / TOPICAL4.6 %w/wExact identifier — unii candidate
6 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
b0778881-d3be-4317-bf5c-056b60d6faef035ebfd1-4673-234f-e054-00144ff8d46c2019-09-05WarningsExact identifier
spl id: b0778881-d3be-4317-bf5c-056b60d6faef
spl set id: 035ebfd1-4673-234f-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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