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RockSauce Warming Massage

43473-076, RockSauce Warming Massage Cream

Approved
Approval ID

b679ed7b-9d88-4eff-9743-567affe0fe2b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Nantong Health & Beyond Hygienic Products Inc.

DUNS: 421280161

Products 1

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

MENTHOL, METHYL SALICYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43473-076
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
MENTHOL, METHYL SALICYLATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (14)

ALOE VERA LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
AMINOMETHYL PROPANOLInactive
Code: LU49E6626Q
Classification: IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERInactive
Code: W59H9296ZG
Classification: IACT
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZ
Classification: IACT
CAPSAICINInactive
Code: S07O44R1ZM
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
POTASSIUM CETYL PHOSPHATEInactive
Code: 03KCY6P7UT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MENTHOLActive
Quantity: 100 mg in 1 mL
Code: L7T10EIP3A
Classification: ACTIB
METHYL SALICYLATEActive
Quantity: 200 mg in 1 mL
Code: LAV5U5022Y
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

Package Labeling:

Label 2

Label 1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/27/2025

USES:

Provides soothing heat to sore muscles and joints.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/27/2025

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/27/2025

ACTIVE INGREDIENT

Menthol 10%

Methyl Salicylate 20%

PURPOSE

Topical Analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/27/2025

WARNINGS:

For external use only.

When using this product,

do not take by mouth or place in nostrils, apply to wounds or damaged skin. Use as directed.

Ask a health professional before use

if you have senstive skin or are pregnant or breastfeeding. Discontinue use if irritation occurs.

Keep out of reach of children.

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or youger.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/27/2025

DIRECTIONS:

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68°to 77°F (20° to 25°C)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/27/2025

INACTIVE INGREDIENTS:

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, AMINOMETHYL PROPANOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ARNICA MONTANA FLOWER EXTRACT, CAPSAICIN, CETEARYL ALCOHOL, MALTODEXTRIN, PHENOXYETHANOL, PHENOXYETHANOL ETHYLHEXYLGLYCERIN, POTASSIUM CETYL PHOSPHATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, WATER

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RockSauce Warming Massage - FDA Drug Approval Details