FDA.reportPublic FDA data

AVCOO Pain Relief Roll-on

Manufacturer
ADP Health Limited
Effective date
2025-01-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:48

Label at a glance#

ProductAVCOO Pain Relief Roll-on
Active ingredientMENTHOL
Label structure13 sections

Storage and handling

Other Information store in a dry place at room temperature between 20-25C (77-86F) and away from direct sunlight

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Menthol 4%

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

INDICATIONS & USAGE SECTION

Uses

Temporary relief from minor aches and pains of sore muscles and joints

WARNINGS SECTION

Warnings

  • Please read all directions and warnings as follows and use only as directed. For external use only.
  • Flammable:Keep away from excessive heat and open flame
  • Do not bandage tightly or use with heating pad or device
  • Avoid contact with eyes
  • Do not apply to wounds or damaged skin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children or pets. If swallowed, get medical help or contact a Poison Control Center right away

PREGNANCY SECTION

If pregnant or breast-feeding,ask a healthcare professional before use

OTC - DO NOT USE SECTION

Do not use

  • if you are allergic to the listed ingredients
  • if the package arrives damagedor opened
  • at the same time as other topical analgesics
  • on mucous membrances, cuts, broken, swollen, or irritated skin

OTC - DO NOT USE SECTION

Do not use

  • if you are allergic to the listed ingredients
  • if the package arrives damagedor opened
  • at the same time as other topical analgesics
  • on mucous membrances, cuts, broken, swollen, or irritated skin

OTC - STOP USE SECTION

Stop Use and Ask a Doctor

if condition worsens, or if syptoms persist for more than 7 days or clear up and occur again within a few days.

if you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, and blistering

DOSAGE & ADMINISTRATION SECTION

Directions 

  • Rub a thin film over the affected area no more than 3-4 times daily
  • Wash hands after use with cold water
  • Children under 12 years of age: do not use, consult a doctor

STORAGE AND HANDLING SECTION

Other Information

  • store in a dry place at room temperature between 20-25C (77-86F) and away from direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arctium Lappa Extract, Arnica Montana Flower Extract, Boswellia Serrata Extrac, Calendula Officinalis Flower Extract,  Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue NO.1, FD&C Yellow No.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, IsopropyI Myristate, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Tocopheryl Acetate, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148430menthol 4 % Topical CreamPSN2
1148430menthol 40 MG/ML Topical CreamSCD2
1148430menthol 4 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84992-001-01AVCOO Pain Relief Roll-on74 mL in 1 BOTTLECREAM742
84992-001-02AVCOO Pain Relief Roll-on1 in 1 CASECREAM12
84992-001-02AVCOO Pain Relief Roll-on74 mL in 1 BOTTLECREAM742
84992-001-03AVCOO Pain Relief Roll-on74 mL in 1 BOTTLECREAM742
84992-001-03AVCOO Pain Relief Roll-on2 in 1 CASECREAM22
84992-001-04AVCOO Pain Relief Roll-on74 mL in 1 BOTTLECREAM742
84992-001-04AVCOO Pain Relief Roll-on3 in 1 CASECREAM32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84992-001AVCOO PAIN RELIEF ROLL-ON (MENTHOL) CREAM [ADP HEALTH LIMITED]2Current NDC, 7 package rows20250106_e0bb77b2-45ee-45fa-9659-9c7d99bb20dc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84992-00184992-001-01, 84992-001-02, 84992-001-03, 84992-001-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ARCTIUM LAPPA WHOLE73070DU1LAIACT
ARNICA MONTANA FLOWER WATERU7L2JP51PRIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
CAMPHOR, (-)-213N3S8275IACT
CARBOMER 934Z135WT9208IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AVCOO Pain Relief Roll-onMENTHOLADP Health Limitede0bb77b2-45ee-45fa-9659-9c7d99bb20dc2025-01-05WarningsExact identifier
ndc (package): 84992-001-01
ndc (package): 84992-001-03
ndc (package): 84992-001-02
ndc (package): 84992-001-04
ndc (product): 84992-001
ndc11 (package): 84992000102
ndc11 (package): 84992000103
ndc11 (package): 84992000104
ndc11 (package): 84992000101
spl id: 2af0c265-3f2c-b0fb-e063-6294a90ab5a1
spl set id: e0bb77b2-45ee-45fa-9659-9c7d99bb20dc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.