FDA.reportPublic FDA data

991 ActivICE spray

Manufacturer
Medline Industries, LP
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:43:21

Label at a glance#

ProductActivICE
Active ingredientMENTHOL
Label structure9 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 over 12 years: spray directly onto affected area without the need to rub, massage or bandage repeat if necessary, but do not apply more than 4 times daily. Children 12 years or younger: ask 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.

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 a 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 helop or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

  • spray directly onto affected area without the need to rub, massage or bandage
  • repeat if necessary, but do not apply more than 4 times daily.

Children 12 years or younger: ask a doctor.

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, peppermint oil, SD alcohol 39C, water.

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA
www.medline.com
1-800-MEDLINE (633-5463)
REF: MDSAICESPRY, V2 RJ21MFO

REF: MDSAICESPRYR, V2 RJ21MFO

Package Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label RH19MFOLabel RH19MFOLabel V3 RJ21MFOLabel V3 RJ21MFO

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2119854ActivICE 8 % Topical SprayPSN6
351286menthol 8 % Topical SprayPSN6
2119854menthol 80 MG/ML Topical Spray [ActivICE]SBD6
351286menthol 80 MG/ML Topical SpraySCD6
2119854ActivICE 80 MG/ML Topical SpraySY6
351286menthol 8 % Topical SpraySY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-991-04ActivICE113.4 g in 1 BOTTLE, SPRAYSPRAY113.46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-991ACTIVICE (MENTHOL) SPRAY [MEDLINE INDUSTRIES, LP]6Current NDC, Legacy NDC, 1 package rows20241215_8414aea2-52b5-4221-e053-2a91aa0a622e.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-99153329-991-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALCOHOL3K9958V90MIACT
EUCALYPTUS OIL2R04ONI662IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
MENTHOLL7T10EIP3AACTIB
GLUCOSAMINE SULFATE1FW7WLR731IACT

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, LP8414aea2-52b5-4221-e053-2a91aa0a622e2024-11-12WarningsExact identifier
ndc (package): 53329-991-04
ndc (product): 53329-991
ndc11 (package): 53329099104
spl id: 26bebd7d-b1e7-5e7e-e063-6394a90a273a
spl set id: 8414aea2-52b5-4221-e053-2a91aa0a622e

Reported adverse events (FAERS/openFDA)#

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