SOLID ROOTS ROLL-ON RELIEF

Manufacturer
RENU LABORATORIES, INC.
Effective date
2022-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:50

Label at a glance#

ProductSOLID ROOTS ROLL-ON RELIEF
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 3 percent

OTC - PURPOSE SECTION

Topical Anesthetic

INDICATIONS & USAGE SECTION

Uses

for temporary relief of minor aches and pains of muscles and joints associated with

  • bruises
  • sprains
  • arthritis
  • strains

RECENT MAJOR CHANGES SECTION

Change that is not substantive (Date change for a cloned submission

Dosage and Administration - only a date change

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

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children twelve years of age and older,

apply to affected area no more than ten times a day as needed for pain

children under twelve years of age do not use, consult a doctor

INACTIVE INGREDIENT SECTION

Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) Extract, Deionized Water, Citrus Paradisi (Grapefruit) Extract, Hippophae Rhamnoides (Sea Berry) Fruit Oil, Hippophae Rhamnoides (Sea Berry) Seed Oil, Hydroxyethyl Cellulose, Isopropyl Alcohol, Lobelia Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Menth Piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate, Hamamelis Virginiana (Witch Hazel)

OTC - QUESTIONS SECTION

Questions? Comments ?

HELLO@AUTHENTICBLENDS.COM

AUTHENTIC BLENDS, LLC

HAVERTOWN, PA 19083

PRODUCT MULTI-LAYER LABEL Page 1 of 3 Page 2 of 3 Page 3 of 3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL PG 2 OF 3LABEL PG 2 OF 3LABEL PG 1 OF 3LABEL PG 1 OF 3

LABEL PG 3 OF 3_ENDLABEL PG 3 OF 3_END

LABEL IS A MULTI-LAYER. PAGE 1, PAGE 2 AND PAGE 3 ALL PART OF THE PEEL BACK LABEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-481-012025-01-30C16284748780-12cef2736-782a-d83d-e063-dadaa90ab31fSolid Roots AUTHENTIC BLENDS Roll-On Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-481-01SOLID ROOTS ROLL-ON RELIEF28 g in 1 BOTTLE, WITH APPLICATORLIQUID281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-481SOLID ROOTS ROLL-ON RELIEF (MENTHOL 3 PERCENT) LIQUID [RENU LABORATORIES, INC.]1Legacy NDC, 1 package rows20220615_e15775a3-833e-14ae-e053-2995a90a5ece.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-48176348-481-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
e15775a3-833d-14ae-e053-2995a90a5ecee15775a3-833e-14ae-e053-2995a90a5ece2022-06-13WarningsExact identifier
spl id: e15775a3-833d-14ae-e053-2995a90a5ece
spl set id: e15775a3-833e-14ae-e053-2995a90a5ece

Reported adverse events (FAERS/openFDA)#

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