Indications and uses
Temporarily relieves minor pain associated with: arthritis muscle strains simple backache bursitis cramps tendonitis muscle sprains bruises
Soundbody Cold and Hot Pain Relief
- Manufacturer
- Kareway Product, Inc.
- Effective date
- 2022-03-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-05-31 23:48:48
Label at a glance#
ProductSoundbody Cold and Hot Pain Relief
Active ingredientMENTHOL
Label structure8 sections
Dosage and administration
Adults and children over 12 years: Remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle Carefully remove backing from patch Apply one patch to affected area Repeat as necessary, but no more than 4 times daily Children under 12 years of age: Ask a doctor
Storage and handling
store at room temperature
Label contents#
Full prescribing information#
Active Ingredient
Menthol 5%
Purpose
Topical analgesic
Uses
Temporarily relieves minor pain associated with:
- arthritis
- muscle strains
- simple backache
- bursitis
- cramps
- tendonitis
- muscle sprains
- bruises
Warnings
For external use only
When using this product
- use only as directed
- do not bandage tightly
- do not use a heating pad
- avoid contact with eyes and mucous membrane
- do not apply to wounds or damaged skin
- do not use if you are allergic to any ingredients of this product
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- irritation develops
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children over 12 years:
- Remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
- Carefully remove backing from patch
- Apply one patch to affected area
- Repeat as necessary, but no more than 4 times daily
Children under 12 years of age: Ask a doctor
Other information
store at room temperature
Inactive ingredients
dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water
package label
Cold and Hot Pain Relief Patch
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67510-0287-2 | 2024-01-30 | C162847 | 48780-1 | 9d75b9d0-0c31-f424-e053-dadaa90a57ce | Soundbody Cold and Hot Pain Relief |
| 67510-0287-2 | 2020-05-20 | C162847 | 48780-1 | 9d75b9d0-0c31-f424-e053-dadaa90a57ce | Soundbody Cold and Hot Pain Relief |
| 67510-0287-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0c31-f424-e053-dadaa90a57ce | Soundbody Cold and Hot Pain Relief |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67510-0287-2 | Soundbody Cold and Hot Pain Relief | 2 in 1 POUCH | PATCH | 2 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67510-0287 | SOUNDBODY COLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.] | 6 | Legacy NDC, 1 package rows | 20220322_6bf338ea-f043-75dd-e053-2991aa0a408a.zip |
Products#
Every source-derived product name is available through these pages.
- Soundbody Cold and Hot Pain Relief
- Menthol
- POLYACRYLIC ACID (8000 MW)
- POLYSORBATE 80
- SODIUM POLYACRYLATE (8000 MW)
- GLYCERIN
- DIHYDROXYALUMINUM AMINOACETATE
- KAOLIN
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- TARTARIC ACID
- TITANIUM DIOXIDE
- POVIDONE
- MINERAL OIL
- PETROLATUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67510-0287 | 67510-0287-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYACRYLIC ACID (8000 MW) | 73861X4K5F | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SODIUM POLYACRYLATE (8000 MW) | 285CYO341L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| DIHYDROXYALUMINUM AMINOACETATE | DO250MG0W6 | IACT |
| KAOLIN | 24H4NWX5CO | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| POVIDONE | FZ989GH94E | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| dac50386-2956-5467-e053-2a95a90a4828 | 6bf338ea-f043-75dd-e053-2991aa0a408a | 2022-03-21 | Warnings | dac50386-2956-5467-e053-2a95a90a4828 6bf338ea-f043-75dd-e053-2991aa0a408a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.