BIOFREEZE DRY STICK- menthol stick

BioFreeze Dry Stick by

Drug Labeling and Warnings

BioFreeze Dry Stick by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient:

Menthol 15%

Purpose:

Pain Relieving Stick

PURPOSE

Active ingredient:

Menthol 15%

Purpose:

Pain Relieving Stick

Uses

Uses:

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

■ arthritis

■ strains

■ bruises

■ sprains

WARNINGS

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 the eyes or on 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

Stop use and ask a doctor if
■ you experience pain, swelling or blistering of the skin
■ condition worsens, or if symptoms persist for more than 7 days or clear
up and occur again within a few days
■ arthritic pain persists for more than 10 days, or redness is present

KEEP OUT OF REACH OF CHILDREN

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.

Directions

Directions

■ adults and children 12 years of age and older: turn dial and apply a thin
film by rubbing over affected area not more than 3 to 4 times daily.
■ children under 12 years of age: consult a physician
■ wash hands after use with cool water

OTHER SAFETY INFORMATION

Other information

■ store at 20-25°C (68-77°F)
■ store in a cool dry place away from direct sunlight

INACTIVE INGREDIENT

Inactive ingredients

alpha-tocopherol acetate, arachidic acid, c15-19 alkane, hydrogenated
castor oil, lauric acid, linoleic acid, linolenic acid, menthyl ethylamido oxalate,
myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, stearic acid

QUESTIONS

Questions or comments? 1-866-682-4639

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOFREEZE DRY STICK 
menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.15 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ARACHIDIC ACID (UNII: PQB8MJD4RB)
C15-19 ALKANE (UNII: CI87N1IM01)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
OLEIC ACID (UNII: 2UMI9U37CP)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
PARAFFIN (UNII: I9O0E3H2ZE)
MENTHYL ETHYLAMIDO OXALATE (UNII: G2MB8B7PSM)
PALMITIC ACID (UNII: 2V16EO95H1)
MYRISTIC ACID (UNII: 0I3V7S25AW)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAURIC ACID (UNII: 1160N9NU9U)
LINOLENIC ACID (UNII: 0RBV727H71)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-230-23	1 in 1 CARTON	12/28/2024
1		22 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/28/2024

Labeler - RB Health (US) LLC (081049410)