The following Structured Product Label (SPL) was submitted to the FDA by Naturalcare for the product Sore Throat (NDC 70163-0200). 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 ingredient:, purpose:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each spray) Capsicum Annuum 6X 0.08%, Echinacea 1X 0.08%, Eucalyptus Globulus 1X 0.08%, Lycopodium Clavatum 4X 0.08%, Mentha Piperita 6X 0.08%, Phytolacca Decandra 4X 0.08%, Thymus Vulgaris 1X 0.08%, Zincum Gluconicum 2X 0.08%.
Capsicum Annuum – burning in throat, Echinacea – sore throat, mucus in throat, Eucalyptus Globulus – throat burns, throat inflamed, Lycopodium Clavatum – sore throat, Mentha Piperita – hoarseness, throat dry, swallowing painful, Phytolacca Decandra – tonsillitis, cannot swallow even water, Thymus Vulgaris – sore throat, cough, Zincum Gluconicum – difficulty swallowing, raw, scratching pain*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
May help temporarily relieve ■ sore throat pain ■ pain with swallowing ■ hoarseness ■ throat irritation*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Stop use and ask a doctor if
■ symptoms worsen, do not improve after 7 days or new symptoms occur
■ you have a severe or persistent sore throat or sore throat accompanied by high fever, nausea and vomiting. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is missing or open.
■ Store tightly closed at room temperature (65-80°F)
In case of overdose, get medical help or contact a Poison Control Center right away.
Adults and children over 12 years of age:
■ use 2-4 sprays in the back of the throat every 4 hours or as needed
■ consult a physician for use in children under 12 years of age
20% alcohol, fructose, glycerin, natural peppermint oil, natural wintergreen flavor, purified water
Dist. By NaturalCare
201 Apple Blvd.
Woodbine, IA 51579
www.NaturalCareWorks.com
1-888-280-5672
NaturalCare
Sore Throat Spray
Homeopathic
For Relief of*
Sore Throat
Pain with Swallowing
Raw, Dry, Scratchy Throat
4 FL OZ (120 mL)
* Please review the disclaimer below.
