FDA.reportPublic FDA data

Herb Street Backache and Sore Muscle Relief

Manufacturer
Balassa Laboratories Inc.
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:22:32

Label at a glance#

ProductHerb Street Backache and Sore Muscle Relief
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

Temporary relief of minor aches and pains associated with: simple backache arthritis bruises strains sprains

Dosage and administration

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: do not use; consult a doctor.

Storage and handling

store at room temperature   

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Purpose

OTC - PURPOSE SECTION

  Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains associated with:

  • simple backache
  • arthritis
  • bruises
  • strains
  • sprains

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with eyes and mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness or severe skin irritation occurs
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:apply to affected area not more than 3 to 4 times daily.
Children under 12 years of age: do not use; consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

store at room temperature   

Inactive Ingredients

INACTIVE INGREDIENT SECTION

avocado oil, yellow wax, castor oil, soybean oil, Cannabis Sativa seed oil, glyceryl stearate, phenoxyethanol, tocopheryl acetate, aloe vera leaf extract, ethylhexylglycerin

PRINCIPAL DISPLAY PANEL - 16.8 g Tube in Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Herb Street with Hemp Seed Oil Moisturizer

Backache & Sore Muscle Relief

10% Menthol

Topical Analgesic Stick

NET WT 0.59 oz (16.8 g)

No Mess Stick

Money Back Guranteed

Manufactured by Balassa Laboratories, Inc.

PO Box 291161, Port Orange, FL 32129

Made in the USA from US and Imported Materials

All rights reserved.

All copyrights and trademarks are owned by Balassa Laboratories, Inc.

Carton ImageCarton Image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10107-432-022023-01-31C16284748780-1f386c649-d6b9-0266-e053-dadaa90a7c1aHerb Street Backache and Sore Muscle Relief
10107-432-022023-01-30C16284748780-1f386c649-d6b9-0266-e053-dadaa90a7c1aHerb Street Backache and Sore Muscle Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10107-432-01Herb Street Backache and Sore Muscle Relief16.8 g in 1 TUBESTICK16.83
10107-432-02Herb Street Backache and Sore Muscle Relief1 in 1 CARTONSTICK13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10107-432HERB STREET BACKACHE AND SORE MUSCLE RELIEF (MENTHOL) STICK [BALASSA LABORATORIES INC.]3Current NDC, Legacy NDC, 2 package rows20241004_aeac1b64-8689-4b3d-a41c-db41061257b5.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10107-43210107-432-01, 10107-432-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
AVOCADO OIL6VNO72PFC1IACT
SOYBEAN OIL241ATL177AIACT
CASTOR OILD5340Y2I9GIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MENTHOLL7T10EIP3AACTIB

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
Herb Street Backache and Sore Muscle ReliefMENTHOLBalassa Laboratories Inc.aeac1b64-8689-4b3d-a41c-db41061257b52024-10-01WarningsExact identifier
ndc (package): 10107-432-02
ndc (package): 10107-432-01
ndc (product): 10107-432
ndc11 (package): 10107043201
ndc11 (package): 10107043202
spl id: 230c8850-d74d-02fd-e063-6394a90a30eb
spl set id: aeac1b64-8689-4b3d-a41c-db41061257b5

Reported adverse events (FAERS/openFDA)#

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