FDA.reportPublic FDA data

SUGARLOAF MENTHOL REVIVE MENTHOL PAIN CREAM

Manufacturer
RENU LABORATORIES, LLC | RENU LABORATORIES LLC
Effective date
2025-08-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:11:59

Label at a glance#

ProductSUGARLOAF ORGANICS MENTHOL REVIVE
Active ingredientMENTHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

WARNINGS SECTION

For external use only

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 - 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.

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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REVIVE LABEL 2025REVIVE LABEL 2025

SUGARLOAF BOX 8.21.2025SUGARLOAF BOX 8.21.2025

REFERENCES:

Sugarloaf Organics Revive Menthol Pain Cream

Label and Box AUGUST 2025

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-996-012025-08-27C16284748780-12cef2736-6068-d83d-e063-dadaa90ab31fSUGARLOAF MENTHOL REVIVE MENTHOL PAIN CREAM
76348-996-012025-01-30C16284748780-12cef2736-6068-d83d-e063-dadaa90ab31fSUGARLOAF MENTHOL REVIVE MENTHOL PAIN CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-996-01SUGARLOAF ORGANICS MENTHOL REVIVE1 in 1 BOXCREAM12
76348-996-04SUGARLOAF ORGANICS MENTHOL REVIVE118 mL in 1 JARCREAM1182

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-99676348-996-04, 76348-996-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CANNABIGEROLJ1K406072NIACT
CANNABICHROMENEK4497H250WIACT
PEG-100 STEARATEYD01N1999RIACT
WATER059QF0KO0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
OLIVE OIL6UYK2W1W1EIACT
WITCH HAZEL101I4J0U34IACT
SHEA BUTTERK49155WL9YIACT
LAURETH-7Z95S6G8201IACT
PEPPERMINT OILAV092KU4JHIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
WHITE WAX7G1J5DA97FIACT
STEARIC ACID4ELV7Z65APIACT
COCONUT OILQ9L0O73W7LIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CORN OIL8470G57WFMIACT
CANNABIDIOL19GBJ60SN5IACT
MENTHOLL7T10EIP3AACTIB
CETEARYL GLUCOSIDE09FUA47KNAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUGARLOAF ORGANICS MENTHOL REVIVEMENTHOLRENU LABORATORIES, LLCfa2f9539-b703-a00b-e053-6394a90ae3092025-08-21WarningsExact identifier
ndc (package): 76348-996-04
ndc (package): 76348-996-01
ndc (product): 76348-996
ndc11 (package): 76348099601
ndc11 (package): 76348099604
spl id: 3ce4cb1d-6369-4b5b-e063-6294a90a9e81
spl set id: fa2f9539-b703-a00b-e053-6394a90ae309

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.