Cold Therapy Roll on

Manufacturer: Allegiant Health
Effective date: 2025-07-29
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:49:18

Label at a glance#

ProductCold Therapy Roll on

Active ingredientMENTHOL

Label structure9 sections

Dosage and administration

Shake well before each use. Adults and children over 2 years : • rub a thin film over affected area not more than 3 to 4 times daily • wash hands after use with cool water children under 2 years of age: ask a doctor

Contacts and useful links#

PhoneLabel contact1-888-952-0050

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

Use(s)

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with:

simple backache
arthritis
strains
bruises
sprains

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from excessive heat or open flame

When using this product

OTC - WHEN USING SECTION

• use only as directed

• avoid contact with mucous membranes

• do not apply to wounds or damaged skin

• do not apply to irritated skin or if excessive irritation develops

• do not bandage tightly or use with heating pad or device

• children 2 years to under 12 years of age: use only under adult supervision

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you experience pain, swelling or blistering of the skin
• condition worsens, or symptoms persist for more then 7 days or clear up and occur again
within a few days

• arthritic pain persists for more then 10 days, or redness is present, or in
conditions affecting children under 12 years of age

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

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before each use.

Adults and children over 2 years:

• rub a thin film over affected area not more than 3 to 4 times daily

• wash hands after use with cool water

children under 2 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Store at 15ºC - 30ºC (59ºF - 86ºF).

Inactive ingredients

INACTIVE INGREDIENT SECTION

blue 1, carbomer, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water, yellow 5

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
415974	menthol 4 % Topical Gel	PSN	2
415974	menthol 0.04 MG/MG Topical Gel	SCD	2
415974	menthol 4 % Topical Gel	SY	2

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Code 128	X004W1BJWR		483---cold-therapy-roll-on-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69168-483-67	Cold Therapy Roll on	74 mL in 1 BOTTLE	GEL	74		2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Cold Therapy Roll on
MENTHOL
BLUE 1
CARBOMER
ISOPROPYL ALCOHOL
MAGNESIUM SULFATE
SODIUM HYDROXIDE
WATER
YELLOW 5

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69168-483	69168-483-67

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
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
BLUE 1	H3R47K3TBD	IACT
CARBOMER	0A5MM307FC	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
MAGNESIUM SULFATE	DE08037SAB	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT
YELLOW 5	I753WB2F1M	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold Therapy Roll on	COLD THERAPY ROLL ON	Allegiant Health	36463acb-7c28-416f-a45f-a93f0be5692b	2025-07-29	Warnings	Exact identifier ndc (package): 69168-483-67 ndc (product): 69168-483 ndc11 (package): 69168048367 spl id: bb264a96-9bd7-4230-b80f-3c62c0c80cf8 spl set id: 36463acb-7c28-416f-a45f-a93f0be5692b

Reported adverse events (FAERS/openFDA)#

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