FDA.reportPublic FDA data

996 ActivICE™ Extra Strength Temporary Pain Relief, Spray

Manufacturer
Medline Industries, LP
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:53:36

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: spray 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 10.0%

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

Do not puncture or incinerate. Contents under pressure.

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:

  • spray 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

SPL UNCLASSIFIED SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

boswellia serrata extract, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerine, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, water (USP)

Questions or comments?

SPL UNCLASSIFIED SECTION

1-800-MEDLINE (633-5463)

Manufacturing information

SPL UNCLASSIFIED SECTION

REF: MDSAICESPRY4

Not made with Natural Rubber Latex. Keep product upright. Handle with care. Protect from freezing, avoid excessive heat.

www.medline.com Manufactured in USA for: Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA. 1-800-MEDLINE

*This product is not manufactured or distributed by Reckitt Benckiser Group PLC and/or its subsidiaries, owner of the registered trademark Biofreeze®.

RECENT MAJOR CHANGES SECTION

Changes to the indications and usage section on April 2026

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

53329-99653329-996

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
667889menthol 10 % Topical SprayPSN6
667889menthol 100 MG/ML Topical SpraySCD6
667889menthol 10 % Topical SpraySY6

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130193489010360GTIN-13: 0193489010360
EAN-13: 0193489010360
GTIN-12: 193489010360
UPC-A: 193489010360
GTIN storage (14 digits): 00193489010360		53329-996 V5 RJ25MFO.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-996-04ActivICE118 mL in 1 BOTTLESPRAY1186

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-99653329-996-04

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
INDIAN FRANKINCENSE4PW41QCO2MIACT
EUCALYPTUS OIL2R04ONI662IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
ALCOHOL3K9958V90MIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
WATER059QF0KO0RIACT
PEPPERMINT OILAV092KU4JHIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT

Source Document#

Source XML · Source PDF

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, LP98fa9a34-0e1e-0997-e053-2a95a90ac77d2025-10-23WarningsExact identifier
ndc (package): 53329-996-04
ndc (product): 53329-996
ndc11 (package): 53329099604
spl id: 41d71f1f-b6a8-5401-e063-6294a90a19d3
spl set id: 98fa9a34-0e1e-0997-e053-2a95a90ac77d

Reported adverse events (FAERS/openFDA)#

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