Biofreeze

Biofreeze

Drug Labeling and Warnings

Drug Details

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BIOFREEZE- menthol spray 
Performance Health LLC
Reference Label Set Id: bceb0d38-bb4f-4048-bfea-06a508e06255

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Biofreeze

Drug Facts

Active Ingredients

Menthol USP 10.5%

Purpose

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

Warnings: 

For external use only.

Flammable: Keep away from excessive heat or open flame.

Contents Under Pressure. Do Not Puncture Or Incinerate Do Not Store At Temperature Above 120°F

Ask a Doctor Before Using If You Have:

 Sensitive skin

When using this product:

• Avoid contact with the eyes or mucous membranes; Do not apply to wounds or damaged skin; Do not use with other ointments, creams, sprays or liniments; Do not apply to irritated  skin or if excessive irritation develops; Do not bandage; Wash hands after use with cool water; Do not use with heating pad or device; Store in a cool dry place

Stop use and ask a doctor If:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

If pregnant or breast-feeding:

Ask a health professional before use

Keep out of reach of children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions:

Adults andchildren 12 years of age and older: Spray on to the affected areas not more than 4 times daily; massage not necessary
Children under 12 years of age: Consult physician

Inactive Ingredients:

Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

Questions or Comments?

1-800-246-3733

Package Labeling: 59316-114-25

BIOFREEZE 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	105 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
JUNIPER BERRY (UNII: O84B5194RL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-114-50	10 in 1 BOX	02/19/2014	12/31/2021
1		1 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 59316-114-25	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/19/2014
3	NDC: 59316-114-30	473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/19/2014
4	NDC: 59316-114-10	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/19/2014

Labeler - Performance Health LLC (794324061)

Establishment
Name	Address	ID/FEI	Business Operations
American Spraytech, LLC		137135237	pack(59316-114)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		557434805	manufacture(59316-114)

Revised: 10/2019

Document Id: 95face5e-d4ac-1aaa-e053-2995a90adb64

34390-5

Set id: 4c798b06-6ee5-41d1-8a14-f6889512ade3

Version: 12

Effective Time: 20191028

 

Performance Health LLC