FDA.reportPublic FDA data

Muscle Balm

Manufacturer
Natural Essentials, Inc.
Effective date
2024-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:41

Label at a glance#

ProductMuscle Balm
Active ingredientMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: Over-Exertion Simple backache Arthritis Strains Sprains

Dosage and administration

Adults and children 12 years of age and over: rub on affected area; repeat 3 to 4 times daily Children under 12 years of age: consult doctor before use.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 11 %

Menthol 11%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • Over-Exertion
  • Simple backache
  • Arthritis
  • Strains
  • Sprains

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not apply to open wounds or damaged skin
  • do not bandage or use a heating pad

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • severe skin irritation occurs
  • pain persists for more than 7 days
  • pain clears up then recurs a few days later

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center immediately.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding,ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

SPL UNCLASSIFIED SECTION

Adults and children 12 years of age and over:rub on affected area; repeat 3 to 4 times daily

SPL UNCLASSIFIED SECTION

Children under 12 years of age:consult doctor before use.

Other Information

OTHER SAFETY INFORMATION

This product may cause allergic reaction in some individuals. Test on small area before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cajeput Oil, Cassia Oil, Clove Oil, Dementholized Mint Oil, Paraffin, Petrolatum

Principal Display Panel – 18 g Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATURE'S OIL
Muscle Balm

Intense Strength

Muscle Relieving Ointment

Net wt 0.63 oz (18 g)

Figure
Figure

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1089847camphor 11 % / menthol 11 % Topical OintmentPSN2
1089847camphor 0.11 MG/MG / menthol 0.11 MG/MG Topical OintmentSCD2
1089847camphor 11 % / menthol 11 % Topical OintmentSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-142-63Muscle Balm18 g in 1 JAROINTMENT182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-142MUSCLE BALM (MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)) OINTMENT [NATURAL ESSENTIALS, INC.]2Current NDC, Legacy NDC, 1 package rows20241006_16918ba3-2e07-4232-9ed3-4c7751796cd2.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66902-14266902-142-63

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAJUPUT OILJ3TO6BUQ37IACT
CHINESE CINNAMON OILA4WO0626T5IACT
CLOVE OIL578389D6D0IACT
PEPPERMINT OIL TERPENELESS4CA0UO1N3ZIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

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
Muscle BalmMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)Natural Essentials, Inc.16918ba3-2e07-4232-9ed3-4c7751796cd22024-10-04WarningsExact identifier
ndc (package): 66902-142-63
ndc (product): 66902-142
ndc11 (package): 66902014263
spl id: 23a87d73-3b5f-22f4-e063-6394a90a3876
spl set id: 16918ba3-2e07-4232-9ed3-4c7751796cd2

Reported adverse events (FAERS/openFDA)#

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