Ear Rx Liquid
FDA Label NDC 69390-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Miami Beach Pediatrics Pa for the product Ear Rx (NDC 69390-001). 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 active ingredients (hpus*):, other, uses:, warnings:, otc - keep out of reach of children, directions:, other information:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Hpus*):

Equal amounts of: Aconitum nap 6X, Baryta carb 10X, Belladonna 9X, Calc carb 6X, Capsicum 9X, Carbo veg 12X, Causticum 8X, Chamomilla 9X, Ferrum phos 9X, Hepar sulph calc 10X, Kali mur 10X, Lachesis 8X, Lycopodium 6X, Mercurius sol 12X, Natrum mur 6X, Plantago 9X, Pulsatilla 9X, Silicea 9X, Sulphur 6X, Verbascum 6X.

Other

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

Uses:

Temporarily relieves inflammation and pain in the ear from infection.

Warnings:

  • This product is to be used under the supervision of your healthcare provider.
  • If symptoms worsen or persist for more than 5 days, consult your practitioner.
  • IF PREGNANT OR NURSING, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

  • KEEP OUT OF THE REACH OF CHILDREN.

Directions:

Shake well and take 5 drops under tongue 3 times a day for 10 days. Take at least 15 minutes away from eating or drinking.

Other Information:

Do not use if cap seal is broken. Store in a cool, dry place.

Inactive Ingredients:

Citric Acid, Potassium Sorbate, Purified Water, Vegetable Glycerin.

Otc - Purpose

Ear Infections

* Please review the disclaimer below.