Otc - Active Ingredient
Allantoin 0.5%
Menthol 0.5%
Al0040600 Alba Cooling Aloe Burn Relief
FDA Label NDC 61995-2406
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Hain Celestial Group, Inc for the product Al0040600 Alba Cooling Aloe Burn Relief (NDC 61995-2406). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Mentol - Topical Analgetic
Allantoin - Skin Protectant
Indications & Usage
- Provides cooling pain relieve
- Skin protection and first aid for the temporary relief of pain and itching associated with sunburn, minor burns, minor skin irritations, insect bites, minor cuts and scrapes
Warnings
For external use only. Avoid contact with eyes, mouth and mucous membranes. Do not use on deep puncture wounds, animal bites or serious burns. Do not puncture or incinerate. Contents under preassure .Do not store at temperature above 120°. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if condition worsens, lasts more than 7days or clears up and occurs again in within a few days or if skin rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.
Dosage & Administration
Adults and children 2 years old and older: apply to affected area up to 4 times daily or as directed by doctor. Hold 4-6 inches away from body when spraying. Do not spray directly on face and avoid breathing mist. Sprayon hand and apply to face.Use in well-ventiled area.
Children under 2 years of age : ask a doctor.
Inactive Ingredient
Aquq (Water),Glycerin, Caprylyl/Capric Glucoside, Aloe Barbadensis Leaf Juice, Cananga Odarata Flower Oil, Mentha Piperita (Peppermint) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Caprylic/Capric Trigluceride, Citric Acid, Terpineol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Hexyl Cinnamal, Hydroxycitronellol, Limonene, Linalool.
Otc - Questions
Questions?Visit www.albabotanica.com or call 888-659-7730
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