MedPath

Golden Remedy Pain Relief Balm

Approved
Approval ID

3c6b0114-0bc9-a150-e063-6394a90a191d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 15, 2025

Manufacturers
FDA

GOLDEN CARE BOTANICALS LLC

DUNS: 140292549

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Menthol, Camphor Topical Analgesic

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code87037-001
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Menthol, Camphor Topical Analgesic
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 15, 2025
FDA Product Classification

INGREDIENTS (12)

BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
MENTHOLActive
Quantity: 4.8 g in 4.8 g
Code: L7T10EIP3A
Classification: ACTIB
GINGER OILInactive
Code: SAS9Z1SVUK
Classification: IACT
COCOA BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
CAMPHOR (NATURAL)Active
Quantity: 4.8 g in 4.8 g
Code: N20HL7Q941
Classification: ACTIB
AVOCADO OILInactive
Code: 6VNO72PFC1
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
MANGIFERA INDICA (MANGO) SEED BUTTERInactive
Code: 4OXD9M35X2
Classification: IACT
AVOCADO SEEDInactive
Code: 5I4J7H930A
Classification: IACT
HELICHRYSUM GYMNOCEPHALUM WHOLEInactive
Code: 0369G6I64W
Classification: IACT
FRANKINCENSEInactive
Code: R9XLF1R1WM
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, D-Inactive
Code: A7E6112E4N
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/8/2025

85g NDC 87937-001-0257g NDC 87937-001-01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/8/2025

Route of Administration:Topical

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/8/2025

Topical analgesic for temporary relief of minor aches and pain of muscles and joints associated with backach, arthritis, strains, brusies, and sprains

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/8/2025

Do not use on open wounds, broken skin, or with a heating pad

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/8/2025

Stop use and ask a doctor if: condition worsens, or symptoms persist for more than 7 days.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/8/2025

For external use only

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/8/2025

Inactive ingredients: beeswax, avocado oil, shea butter, cocoa butter, mango butter, menthol crystals, avocado seed powder, camphor, helichrysum, frankincense, ginger oil, vitamin e

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/8/2025

Directions:
Adults and children 12 years and over: Apply to the affected area not more than 3 to 4 times daily.

Route of Administration:Topical (external) use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/8/2025

If swallowed, seek immediate medical attention or contact Poison Control

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