The following Structured Product Label (SPL) was submitted to the FDA by Meditrend, Inc. Dba Progena Professional Formulations for the product Allergena Fragrance (NDC 62713-957). 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, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients: Arnica montana 6X, Bovista 6X, Calcerea carbonica 8X, Carbo vegetabilis 8X, Cicuta virosa 8X, Euphorbium officinarum 6X, Hydrastis canadensis 5X, Petroleum 6X, Phosphorus 8X, Plumbum metallicum 8X, Sulfur 30X
Purpose:Promotes the temporary relief of allergies from Fragrances, Tobacco Smoke, Car Exhaust and Fireplace Smoke.*
Keep Out of Reach of Children.In case of overdose, get medical help or contact a
Poison Control Center right away.
Use: This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.*
Warnings:
Directions: • Shake Well Before Use. • Adults (12 and Older) 12-15 drops under the tongue four to six times daily. In acute phase, take every half hour. • Children (7-12 years)9 drops under the tongue. • Children (2-7 years)6 drops under the tongue. • Infants (0-2 years) 3 drops. Consult a physician for use in children under 12 years of age.
Other Information: Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.
Inactive Ingredients: Demineralized Water and 20% USP Alcohol.
*www.allergena.com/drugdisclaimer
Manufactured for Progena Professional Formulations
4820 Eubank Blvd. NE, ABQ, NM 87111, www.allergena.com
Image Of Label (Fragrance Label)
* Please review the disclaimer below.
