Active Ingredient Section
Menthol (4%)
Ultra Blue
FDA Label NDC 70632-825
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bng Enterprises Dba Herbal Clean for the product Ultra Blue (NDC 70632-825). 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 section, purpose, uses:, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses:
Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, sprains, strains, bruises.
Warnings
For external use only.
When Using This Product
• Do not apply to wounds or damaged skin
• Do not bandage tightly
• Do not use in or near the eyes; if product gets into eyes, rinse thoroughly with water
• Do not use with electric heating pad
Stop Use And Ask A Doctor If
• Condition worsens
• Symptoms last more than 7 days or clear up and occur again within a few days
• A rash or irritation develops
Keep Out Of Reach Of Children
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Adults and children 2 years of age and older, apply directly to affected area; not more than 3 or 4 times daily
• Children under 2 years of age: ask a doctor
Inactive Ingredients:
Purified Water, Propylene Glycol, Emu Oil, Methylsulfonylmethane (msm), Polyacrylamide (and) C13-14 Isoparafin and Laureth-7, C12-15 Alkyl Benzoate, Dimethicone, Dioctyl Adipate (and) Octyl Stearate (and) Octyl Palmitate, White Willow Extract, Propylene Glycol (and) Diazolidinyl Urea (and) Methylparaben (and) Propylparaben, Aloe Vera Gel, Panthenol, Ascorbic Acid, Capsicum Oleoresin, Cornflower Extract, Chamomile Extract, Feverfew Extract, Hypericum Extract, Calendula Extract, Linden Extract, Coriander Oil, Grape Seed Extract, Benzophenone-4, Polysorbate-20, Tetrasodium EDTA, Citric Acid, Fragrance, F D & C Blue #1 Lake
Ultra Blue Tube Front Panel, Back Panel
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