Abdominal Cream
FDA Label NDC 70113-011

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Homeopathic Services Inc. for the product Abdominal Cream (NDC 70113-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, other, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients (HPUS*):

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

Other

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

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

Indications & Usage

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

Warnings

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

  • Keep out of reach of children.

Dosage & Administration

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

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

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)

Otc - Purpose

Temporarily relieves abdominal musculature soreness

* Please review the disclaimer below.