COLD THERAPY ROLL ON gel

Cold Therapy Roll on by

Drug Labeling and Warnings

Cold Therapy Roll on by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Menthol 4%

Purpose

Pain Relieving Gel

Use(s)

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

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame

When using this product

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

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,

ask a health professional before use.

Keep out of reach of children

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

Directions

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

Store at 15ºC - 30ºC (59ºF - 86ºF).

Inactive ingredients

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

Questions/Comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Principal Display Panel

Cold Therapy Roll on

INGREDIENTS AND APPEARANCE

COLD THERAPY ROLL ON 
cold therapy roll on gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-483
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.04 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BLUE 1 (UNII: H3R47K3TBD)
CARBOMER (UNII: 0A5MM307FC)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM SULFATE (UNII: DE08037SAB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
YELLOW 5 (UNII: I753WB2F1M)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-483-67	74 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/29/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/29/2025

Labeler - Allegiant Health (079501930)