The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Inflammation (NDC 57520-0160). 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, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS: Mangosteen 3X, Acai 3X, Aronia 3X, Olibanum 3X, Aconitum napellus 6X, Bryonia 6X, Humulus lupulus 6X, Hydrastis canadensis 6X, Magnesia phosphorica 8X, Rooster comb cartilage 8X, Apis mellifica 200C, Arnica montana 200C, Hypericum perforatum 200C, Rhus toxicodendron 200C, Thuja occidentalis 200C.
INDICATIONS: Relieves these symptoms associated with inflammation: Redness, headache, swelling, heat, pain, loss of function.
KEEP OUT OF REACH OF CHILDREN: In case of overdose, get medical help or contact a Poison Control Center right away.
INDICATIONS: Relieves these symptoms associated with inflammation: Redness, headache, swelling, heat, pain, loss of function.
WARNINGS: If pregnant or breast-feeding, ask a health professional before use.
Do not use if tamper evident seal is broken or missing.
Store in a cool, dry place.
DIRECTIONS: Adults and children 12 and over: Spray twice under the tongue 3 times per day, or as directed by a health care professional.
Children under 12 years of age, consult a physician before use.
INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol.
Distributed by:
Category Creators LLC
Mill Creek, WA 98012
800-951-9271
www.CategoryCreators.com
NDC: 57520-0160-1
CATEGORY CREATORS
INNOVATIVE NUTRITIONAL PRODUCTS
JOE MANGOSTEEN
HOMEOPATHIC
INFLAMMATION
2 FL OZ (60 ml)
Inflammation (Mm1)
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