Biofreeze Dry Stick

Biofreeze Dry Stick
SPL v1
SPL
SPL Set ID 26d62cd2-9209-8cca-e063-6394a90a2028
Route
TOPICAL
Published
Effective Date 2024-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.15 g)
Inactive Ingredients
Arachidic Acid C15-19 Alkane Hydrogenated Castor Oil Oleic Acid Linoleic Acid Paraffin Menthyl Ethylamido Oxalate Palmitic Acid Myristic Acid .alpha.-tocopherol Acetate Stearic Acid Lauric Acid Linolenic Acid Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-28

Description

Active ingredient: Menthol 15% Purpose: Pain Relieving Stick


Medication Information

Warnings and Precautions

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

Description

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

Section 50565-1

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.

Section 51727-6

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

Section 51945-4

Section 53413-1

Questions or comments? 1-866-682-4639

Section 55105-1

Active ingredient:

Menthol 15%

Purpose:

Pain Relieving Stick

Section 55106-9

Active ingredient:

Menthol 15%

Purpose:

Pain Relieving Stick

Section 60561-8

Other information



■ store at 20-25°C (68-77°F)

■ store in a cool dry place away from direct sunlight

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


Structured Label Content

Uses

Uses:

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

■ simple backache

■ arthritis

■ strains

■ bruises

■ sprains

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-866-682-4639

Section 55105-1 (55105-1)

Active ingredient:

Menthol 15%

Purpose:

Pain Relieving Stick

Section 55106-9 (55106-9)

Active ingredient:

Menthol 15%

Purpose:

Pain Relieving Stick

Section 60561-8 (60561-8)

Other information



■ store at 20-25°C (68-77°F)

■ store in a cool dry place away from direct sunlight

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)