MedPath

Capsicum Plaster HOT

84198-007 Capsicum Plaster HOT

Approved
Approval ID

3c28f34a-343d-b297-e063-6294a90accdc

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Guangzhou Su Mai Feng International Trading Co., Ltd.

DUNS: 417686829

Products 1

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

Borneol, Camphor, Menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84198-007
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Borneol, Camphor, Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (10)

GINGERInactive
Code: C5529G5JPQ
Classification: IACT
CINNAMONInactive
Code: 5S29HWU6QB
Classification: IACT
SAFFRONInactive
Code: E849G4X5YJ
Classification: IACT
OSMANTHUS FRAGRANS FLOWERInactive
Code: 4VA0BH57HU
Classification: IACT
WORMWOODInactive
Code: F84709P2XV
Classification: IACT
ARTEMISIA VULGARIS TOP OILInactive
Code: 72Q967Y48V
Classification: IACT
CAMPHOR (NATURAL)Active
Quantity: 0.015 g in 1 g
Code: N20HL7Q941
Classification: ACTIB
BORNEOLActive
Quantity: 0.012 g in 1 g
Code: M89NIB437X
Classification: ACTIB
MENTHOLActive
Quantity: 0.01 g in 1 g
Code: L7T10EIP3A
Classification: ACTIB
EUCALYPTUS OILInactive
Code: 2R04ONI662
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

label2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Temporarily relieves muscle soreness and minorjoint pains in the knees, back, neck, hips,shoulders,elbows

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Borneol 1.2%
Camphor 1.5%
Menthol 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Topical Anaglesic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/12/2025

on wounds or damaged skin
with a heating pad or device
with other ointments,creams, sprays, or liniments
if you are allergic to any ingredients of this product

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/12/2025

use only as directed
avoid contact with the eyes, mucous membranes,or rashes
do not bandage tightly
discontinue use at least one hour before a bath and do not use immediately after a bath

skin reactions such as redness,swelling, blisteringor other discomfort occur
symptoms persist for more than 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/12/2025

lf swallowed accidentally , get medical help or contact with Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/12/2025

Adults and Children above 12 years old:

.Clean and dry the affected area.
.Peel off the large protective film to reveal a smallfilm on the reddish brown patch
.Partially peel back the protective film and applythe exposed part of the patch to the site of pain
.Carefully remove remaining film while pressingthe patch firmly on the skin
.Remove patch from the skin after at most 8-hourapplication.
Children under age of 12: Consult a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Dried ginger
Saffron
Wormwood
Mugwort oil
Osmanthus flower oil
Eucalyptus leaf oil
Cinnamon

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/12/2025

Wash the area to be applied withwarm water and dry it.
Peel off the anti -adhesive layer, stickthe patch on the painful area andsmooth it.
Put the remaining patches back intothe package and seal it after use.

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