MedPath

Rapid Relief

Approved
Approval ID

3b350613-9f7e-94b9-e063-6294a90a4cf7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

RAPID AID VIET NAM COMPANY LIMITED

DUNS: 673067008

Products 1

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

Pain Relief Patch

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83569-008
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pain Relief Patch
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (14)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (120000 MPA.S AT 1%)Inactive
Code: 5F4963KLHS
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
EDETIC ACIDInactive
Code: 9G34HU7RV0
Classification: IACT
SODIUM POLYACRYLATE (8000 MW)Inactive
Code: 285CYO341L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
CAMPHOR (SYNTHETIC)Active
Quantity: 110 mg in 1 1
Code: 5TJD82A1ET
Classification: ACTIB
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUSInactive
Code: 1K713C615K
Classification: IACT
LAUROCAPRAMInactive
Code: 1F3X9DRV9X
Classification: IACT
POLYACRYLIC ACID (800000 MW)Inactive
Code: D0I6NSZ87U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CAPSICUMActive
Quantity: 22 mg in 1 1
Code: 00UK7646FG
Classification: ACTIB
LEVOMENTHOLActive
Quantity: 33 mg in 1 1
Code: BZ1R15MTK7
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/31/2025

labeler-inlabeler- out

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/31/2025

Directions

Adults and children 12 years of age and older:apply to affected area; change patch 1 to 2 times daily

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

How to Apply

Clean and dry affected area

Cut open pouch and remove patch

Remove protective film and apply directly to area of pain

Apply to affected area not more than 3 times daily. Do not leave on skin for more than a total of 8 hours per day

Wash hands with soap after applying patch

Reseal pouch containing unused patches

Children under 2 years of age: do not use, consult a physician

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/31/2025

Active Ingredient(s)

Camphor 110mg +Menthol 33mg + Capsicum Extract 22mg

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 7/31/2025

ask a doctor if:

Condition worsens,

Severe skin irritation occurs

Pain persist for more than 7 days

Symptoms clear up and occur again within a few days.

You experience pain, swelling or blistering, as rare but serious burns can occur

headache or redness occurs

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 7/31/2025

NO NOT USE

do not get into eyes or on mucous membranes. If contact occurs, rinse thoroughly with water

do not apply to wounds, damaged or irritated skin

do not bandage or cover with any type of wrap except clothing

do not use with a heating pad or apply external heat

do not use 1 hour prior to bathing or within 30 minutes after bathing

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/31/2025

Keep out of reach of children

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 7/31/2025

If pregnant or breast feeding:

If pregnant or breast feeding, ask a health professional before use.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/31/2025

PURPOSE

Topical analgesic

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/31/2025

QUESTION

None

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/31/2025

STOP USE

Condition worsens,

Severe skin irritation occurs

Pain persist for more than 7 days

Symptoms clear up and occur again within a few days.

You experience pain, swelling or blistering, as rare but serious burns can occur

headache or redness occurs

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/31/2025

When using this product::

Use only as directed

do not get into eyes or on mucous membranes. If contact occurs, rinse thoroughly with water

do not apply to wounds, damaged or irritated skin

do not bandage or cover with any type of wrap except clothing

do not use with a heating pad or apply external heat

do not use 1 hour prior to bathing or within 30 minutes after bathing

WARNINGS SECTION

LOINC: 34071-1Updated: 7/31/2025

Warnings

For external use only.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/31/2025

Other information

This product may cause allergic reaction on some individuals

Store in cool dry place away from direct sunlight

Store at 15-30°C (59-86°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/31/2025

Inactive ingredients

Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Dihydroxyaluminum aminoacetate, DMDM hydantoin, Edetic acid, Glycerin, Laurocapram, Polyacrylic acid, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/31/2025

STORE

Store in cool dry place away from direct sunlight

Store at 15-30°C (59-86°F)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/31/2025

Directions

Adults and children 12 years of age and older:apply to affected area; change patch 1 to 2 times daily

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

How to Apply:

Clean and dry affected area

Cut open pouch and remove patch

Remove protective film and apply directly to area of pain

Apply to affected area not more than 3 times daily. Do not leave on skin for more than a total of 8 hours per day

Wash hands with soap after applying patch

Reseal pouch containing unused patches

Children under 2 years of age: do not use, consult a physician

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Rapid Relief - FDA Drug Approval Details