SUGARLOAF ORGANICS MENTHOL REVIVE
SUGARLOAF MENTHOL REVIVE MENTHOL PAIN CREAM
fa2f9539-b703-a00b-e053-6394a90ae309
HUMAN OTC DRUG LABEL
Aug 21, 2025
RENU LABORATORIES, LLC
DUNS: 119451815
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Menthol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (25)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
REFERENCES:
Sugarloaf Organics Revive Menthol Pain Cream
Label and Box AUGUST 2025
INDICATIONS & USAGE SECTION
For temporary relief of minor aches and pains associated with
- arthritis
- simple backache
- muscle strains
- sprains
- bruises
OTC - WHEN USING SECTION
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 SECTION
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 - PURPOSE SECTION
Topical Analgesic
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
**Instructions:**Massage into skin until thoroughtly absorbed. Repeat as needed. Store at room temperature.
WARNINGS SECTION
For external use only
OTC - ACTIVE INGREDIENT SECTION
Menthol 5%
INACTIVE INGREDIENT SECTION
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 SECTION
OTC - QUESTIONS SECTION
Sugarloaf Organics
Drums, PA 18222
P: 570.866.5882
www.sugarloaforganic.com