992 ActivICE roll-on

Manufacturer: Medline Industries, LP
Effective date: 2026-04-13
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:53:35

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

Contacts and useful links#

Websitewww.medline.com

www.medline.com

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 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 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

boswellia serrata extract, carbomer, dimethylsulfone(MSM), eucalyptus oil, glucosamine sulfate, glycerin, peppermint oil, SD alcohol 39C, triethanolamine, water (USP)

Questions or comments?

SPL UNCLASSIFIED SECTION

1-800-MEDLINE (633-5463)

Monday-Friday 9AM-5PM CST

Manufacturing Information

SPL UNCLASSIFIED SECTION

Not made with natural rubber latex. Keep product upright.

Handle with care. Protect from freezing, avoid excessive heat.

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®.

REF: MDSAICEROLL

RECENT MAJOR CHANGES SECTION

Updates to indications and usage section on April 2026

Package Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2264041	ActivICE 8 % Topical Solution	PSN	7
727162	menthol 8 % Topical Solution	PSN	7
2264041	menthol 80 MG/ML Topical Solution [ActivICE]	SBD	7
727162	menthol 80 MG/ML Topical Solution	SCD	7
2264041	ActivICE 8 % Topical Solution	SY	7
2264041	ActivICE 80 MG/ML Topical Solution	SY	7
727162	menthol 8 % Topical Solution	SY	7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-992-69	ActivICE	85 g in 1 BOTTLE, PLASTIC	LIQUID	85		7

Products#

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

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

ActivICE
menthol
CARBOMER 940
ALCOHOL
GLUCOSAMINE SULFATE
TROLAMINE
GLYCERIN
BOSWELLIA SERRATA RESIN OIL
DIMETHYL SULFONE
PEPPERMINT OIL
PEPPERMINT
WATER
EUCALYPTUS OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53329-992	53329-992-69

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
Name	UNII	Kind
CARBOMER 940	4Q93RCW27E	IACT
ALCOHOL	3K9958V90M	IACT
GLUCOSAMINE SULFATE	1FW7WLR731	IACT
TROLAMINE	9O3K93S3TK	IACT
GLYCERIN	PDC6A3C0OX	IACT
BOSWELLIA SERRATA RESIN OIL	5T1XCE6K8K	IACT
DIMETHYL SULFONE	9H4PO4Z4FT	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
WATER	059QF0KO0R	IACT
MENTHOL	L7T10EIP3A	ACTIB
EUCALYPTUS OIL	2R04ONI662	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ActivICE	MENTHOL	Medline Industries, LP	8465b443-abe9-78fb-e053-2a91aa0ac1d8	2026-04-13	Warnings	Exact identifier ndc (package): 53329-992-69 ndc (product): 53329-992 ndc11 (package): 53329099269 spl id: 4f5db354-ecdb-3529-e063-6394a90ae094 spl set id: 8465b443-abe9-78fb-e053-2a91aa0ac1d8

Reported adverse events (FAERS/openFDA)#

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