Otc - Active Ingredient
Active ingredients Purpose
Camphor 2% External Analgesics
Menthol 8% External Analgesics
Kuribl Active Muscle
FDA Label NDC 83111-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Radiance Beauty & Wellness Inc. Dba Saavy Naturals for the product Kuribl Active Muscle (NDC 83111-003). 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, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
Temporary relief of minor aches and pains of muscles and joints associated with strains, bruises, and sprains
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
Indications & Usage
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- excessive skin irritation develops
Warnings
WarningsFor external use only
Do not use on wounds or damaged skin
When using this product
- avoid contact with eyes or mucous membranes
- do not bandage tightly or use with heating pad
If pregnant or breast-feeding ask a health professional before use
Dosage & Administration
Directions
- Apply to affected area not more than 3 to 4 times daily
- After application, wash hands with soaps and water (unless applying to hands).
- Children under the age of 18, consult a doctor before use
Inactive Ingredient
Inactive Ingredients Allantoin, Aloe Barbadensis (Aloe) Leaf Juice, Arnica Montana (Arnica) Flower Extract, Aqua/Purified, Benzyl Alcohol, Butyrospermum parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Gluconolactone, Glycerin (Kosher Vegetable), Glyceryl Stearate Citrate, Glyceryl Stearate SE, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Menthyl Nicotinate, Polyglyceryl-3 Distearate, Polyglyceryl-6 Behenate, Polyglyceryl-6 Stearate, Simmondia chinensis (Jojoba) Seed Oil, Stearyl Alcohol, Tocopherol (Natural Vitamin E), Xanthan Gum
Package Label.Principal Display Panel
kuribl Active
Muscle Cream
All Natural Pain Relief with Camphor & Menthol
3 FL OZ (88.7 mL)
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