FDA.reportPublic FDA data

Abdominal Cream

Manufacturer
Homeopathic Services Inc. | OHM PHARMA INC.
Effective date
2019-09-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:11:28

Label at a glance#

ProductAbdominal Cream
Active ingredientBELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (HPUS*):

Bellis perennis 12X 9%, Calendula Officinalis 12X 3%

SPL UNCLASSIFIED SECTION

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

INDICATIONS & USAGE SECTION

Uses: Tempoarily relieves abdominal muscle pain, stiffness and bruises.

SPL UNCLASSIFIED SECTION

These statements have not been evaluated by the FDA. They are based on documented Homeopathic Materia Medica.

WARNINGS SECTION

Warnings:

  • For external use only. Do not apply to eyes, broken skin.
  • If pregnant or breast-feeding, ask a health professional before use.
  • If swallowed, get medical help or contact a Poison Control Center right away.
  • Do not use if you are allergic to Bellis and Calendula and to any of the inactive ingredients.
  • Use this product only as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: Apply a small amount to affected area 3 times a day.

OTHER SAFETY INFORMATION

Other information: Tamper evident - do not use if cap seal is broken or missing. Store at room temperature.

  • Petroleum, paraben, propylene free
  • Vegan
  • Sulfate free
  • NON-GMO
  • First Aid
  • Aloe Vera
  • Absorbs quickly
  • Non-greasy

INACTIVE INGREDIENT SECTION

Inactive ingredients: Aloe Vera Extract (organic), Borax, Caprylyl Glycol, Emulsifying Wax NF, Organic Coconut Oil, Organic Sunflower Oil, Phenoxyethanol, Purified Water, Vitamin E Oil.

OTC - QUESTIONS SECTION

Questions or comments?

MFG for: HS-Athletics.com

New York, NY 10016

Tel: 212-334-7360

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70113-011-35

HS Athletics

Abdominal Cream

Temporarily relieves adbdominal musculature soreness

TOPICAL HOMEOPATHIC MEDICINE

"This cream specifically designed for the adbdominal musculature, will help y ou recover fast from soreness caused by working out."

-Pierre Fontaine,

HSA founder, homeopath

HS-Athletics.com

3.5 oz (100g)

100g tube label100g tube label

OTC - PURPOSE SECTION

Temporarily relieves abdominal musculature soreness

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70113-011-352021-01-29C16284748780-1ba0f9c33-51ad-a910-e053-dadaa90a0b85Abdominal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70113-011-35Abdominal Cream100 g in 1 TUBECREAM1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70113-011ABDOMINAL CREAM (BELLIS PERENNIS, CALENDULA OFFICINALIS) CREAM [HOMEOPATHIC SERVICES INC. ]2Legacy NDC, 1 package rows20190906_b76b913d-0e6f-4bf9-b982-ebc0fe793e0f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70113-01170113-011-35

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BELLIS PERENNIS2HU33I03UYACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM BORATE91MBZ8H3QOIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYSORBATE 60CAL22UVI4MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PEG-150 STEARATE7BSG7DF10QIACT
STEARETH-20L0Q8IK9E08IACT
COCONUT OILQ9L0O73W7LIACT
SUNFLOWER OIL3W1JG795YIIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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
d9c9cb79-51ee-476f-bf61-03313c17e960b76b913d-0e6f-4bf9-b982-ebc0fe793e0f2019-09-05WarningsExact identifier
spl id: d9c9cb79-51ee-476f-bf61-03313c17e960
spl set id: b76b913d-0e6f-4bf9-b982-ebc0fe793e0f

Reported adverse events (FAERS/openFDA)#

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