FDA.reportPublic FDA data

984 ActivIce gel

Manufacturer
Medline Industries, LP
Effective date
2026-09-01
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
daily-update
Hydrated at
2026-09-03 03:03:59

Label at a glance#

ProductActivICE
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

Adults and children 2 years of age and older: apply directly onto affected area without the need to rub, massage or bandage repeat if necessary, but do not apply more than 3 to 4 times daily wash hands after use Children under 2 years of age: do not use, consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 8.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

Flammable: keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly or use with heating pad
  • do not apply to wounds or damaged skin

Stop use and ask doctor if

OTC - STOP USE SECTION

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • excessive irritation of the skin develops

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:

  • apply directly onto affected area without the need to rub, massage or bandage
  • repeat if necessary, but do not apply more than 3 to 4 times daily
  • wash hands after use

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

Other information

OTHER SAFETY INFORMATION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, triethanolamine, water (USP)

Questions or comments?

OTC - QUESTIONS SECTION

1-800-MEDLINE (633-5463) Monday-Friday 9AM-5PM CST

Manufacturing Information

SPL UNCLASSIFIED SECTION

www.medline.com

Manufactured in USA for: Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE

REF: MDSAICEGELR, MDSAICEGEL, MDSAICE16

RECENT MAJOR CHANGES SECTION

Updated directions [dosage and administration section]

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CuradCuradLabel V3 RF23MFOLabel V3 RF23MFO

MDSAICE16MDSAICE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-984-16ML - Milliliter53329-9846c576af8-8fb5-48c9-a559-ef13eb226fb112025-02-10

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-98453329-984-04, 53329-984-23, 53329-984-25, 53329-984-30, 53329-984-06, 53329-984-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
PENTYLENE GLYCOL50C1307PZGIACT
WATER059QF0KO0RIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
TROLAMINE9O3K93S3TKIACT
PEPPERMINT OILAV092KU4JHIACT
ALCOHOL3K9958V90MIACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
EUCALYPTUS OIL2R04ONI662IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-10-23full-release2026-06-01 01:53:43

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
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
ndc (package): 53329-984-06
ndc (package): 53329-984-30
ndc (package): 53329-984-04
ndc (package): 53329-984-23
ndc (package): 53329-984-25
ndc (package): 53329-984-16
ndc (product): 53329-984
ndc11 (package): 53329098423
ndc11 (package): 53329098404
ndc11 (package): 53329098406
ndc11 (package): 53329098425
ndc11 (package): 53329098416
ndc11 (package): 53329098430
spl id: 5a6e9886-23df-e0ee-e063-6294a90a5e48
spl set id: 834adeb9-38ad-0cfe-e053-2991aa0af82f

Reported adverse events (FAERS/openFDA)#

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