Otc - Active Ingredient
Menthol 5%
Sugarloaf Organics Menthol Revive Cream
FDA Label NDC 76348-996
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Sugarloaf Organics Menthol Revive (NDC 76348-996). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Indications & Usage
For temporary relief of minor aches and pains associated with
- arthritis
- simple backache
- muscle strains
- sprains
- bruises
Warnings
For external use only
Otc - When Using
Do not bandage tightly
- avoid contact with eyes
- do not apply to wounds or damaged skin
- do not use with heating pads or other heating devices.
Otc - Stop Use
Stop use and ask a doctor if
- Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Instructions: Massage into skin until thoroughtly absorbed. Repeat as needed. Store at room temperature.
Inactive Ingredient
Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (Hemp) Seed Oil, with a proprietary blend of terpenes (alpha-bisabolol,
alpha-humulene, beta-caryophyllene, caryophyllene oxide, gualol, linalool),
Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Ethylhexylglycerin, Fragrance, Hemp-derived Cannabichromene (CBC), Cannabidiol (CBD), and Cannabigerol (CBG),
Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Sulfate, Mangifera Indica (Mango) Seed Buter,
Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid
Recent Major Changes
Indications and Usage This is a clone of another product. Only slight changes to wording have happened. Nothing major.
Dosage and Administration - Directions were simplified.
Otc - Questions
Sugarloaf Organics
Drums, PA 18222
P: 570.866.5882
www.sugarloaforganic.com
Package Label.Principal Display Panel
Sugarloaf Organics Revive Menthol Pain Cream
Label and Box
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