Indications and uses
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, and sprains
TopCare Pain Relieving Roll-On Gel Topical Analgesic
- Manufacturer
- Topco Associates LLC | Garcoa, Inc. | SV Labs Toronto Corporation
- Effective date
- 2024-11-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:17:47
Label at a glance#
ProductTopCare Pain Relieving Roll-On Topical Analgesic
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections
Dosage and administration
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Massage not necessary. Children under 2 years of age: Consult a doctor.
Storage and handling
Store in a cool dry place with lid closed tightly
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Menthol 4%
Purpose
Topical analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, and sprains
Warnings
For external use only
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have sensitive skin
When using this product
- Avoid contact with eyes
- Do not apply to wounds or damaged skin
- Do not use with other ointments, creams, sprays or liniments
- Do not apply to irritated skin or if excessive irritation develops
- Do not bandage tightly
- Wash hands after use with cool water
- Do not use with heating pads or heating devices
OTC - STOP USE SECTION
Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.
SPL UNCLASSIFIED SECTION
Flammable
- keep away from excessive heat or open flame
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Massage not necessary.
- Children under 2 years of age: Consult a doctor.
Other information
Store in a cool dry place with lid closed tightly
Inactive ingredients
aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.
Questions or comments?
1-888-423-0139
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label
NDC 36800-290-01
TopCare
health®
COMPARE TO BIOFREEZE® ROLL-ON ACTIVE INGREDIENT*
Cold Therapy
Pain
Relieving
Roll-On Gel
with Menthol 4%
- For Arthritis, Back Pain,
Sore Muscles & Joints - No-Mess Applicator
- Vanishing Scent
- Paraben-Free
• OUR PHARMACISTS •
RECOMMEND
2.5 FL OZ (74 mL)
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code |  topbrnds.com/48zwzv | topcare-pain-relieving-roll-on-topical-analgesic-1.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 36800-290-01 | 2024-11-13 | C162847 | 48780-1 | f386c64a-2164-0266-e053-dadaa90a7c1a | TopCare Pain Relieving Roll-On Gel Topical Analgesic |
| 36800-290-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2164-0266-e053-dadaa90a7c1a | TopCare Pain Relieving Roll-On Gel Topical Analgesic |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-290-01 | TopCare Pain Relieving Roll-OnTopical Analgesic | 74 mL in 1 BOTTLE, WITH APPLICATOR | GEL | 74 | 4 |
Products#
Every source-derived product name is available through these pages.
- TopCare Pain Relieving Roll-On Topical Analgesic
- MENTHOL, UNSPECIFIED FORM
- ALOE VERA LEAF
- ARNICA MONTANA FLOWER
- FD&C BLUE NO. 1
- INDIAN FRANKINCENSE
- CALENDULA OFFICINALIS FLOWER
- GREEN TEA LEAF
- CAMPHOR (SYNTHETIC)
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- Glycerin
- Isopropyl Alcohol
- Isopropyl Myristate
- SILICON DIOXIDE
- Sodium Hydroxide
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- Water
- FD&C YELLOW NO. 5
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-290 | 36800-290-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| TopCare Pain Relieving Roll-On Topical Analgesic | MENTHOL, UNSPECIFIED FORM | Topco Associates LLC | 48589893-ca67-471d-88bc-92014295ab9f | 2024-11-13 | Warnings | 36800-290-01 36800-290 36800029001 d6e69347-6255-4460-97e1-754359314327 48589893-ca67-471d-88bc-92014295ab9f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.