Otc - Active Ingredient
ACTIVE INGREDIENTS (HPUS*): Belladonna 30X, Conium Maculatum 30X, Dulcamara 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X
Ear Inflam Hp
FDA Label NDC 43406-0018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc. for the product Ear Inflam Hp (NDC 43406-0018). 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, indications & usage, warnings, dosage & administration, otc - do not use, references, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
USES: Temporarily relieves throbbing, stitching, roaring, stopped up feeling, earache with nausea, earache that is worse at night, &/or other symptoms of earaches.
Warnings
WARNING:
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.
Dosage & Administration
DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.
Otc - Do Not Use
OTHER INFORMATION: Tamper Seal: "Sealed for your protection."
Do not use if seal is broken or missing.
References
*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.
Inactive Ingredient
INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%
Otc - Questions
QUESTIONS AND COMMENTS?
MFG FOR: Natural Creations / Woodbine, IA / 51579 712.647.1600
LOT:
Otc - Purpose
USES: Temporarily relieves throbbing, stitching, roaring, stopped up feeling, earache with nausea, earache that is worse at night, &/or other symptoms of earaches.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.
Package Label.Principal Display Panel
NDC: 43406-0018-1
EAR INFLAM HP
Earache
HOMEOPATHIC
1 fl oz (30 mL) / 20% Alcohol
UPC: 877730001269
Image Of Label (Earinflamhp)
* Please review the disclaimer below.
