Biofreeze

Biofreeze

Drug Labeling and Warnings

Drug Details

k">

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.

----------

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

Label8

BIOFREEZE 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59316-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL105 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59316-114-5010 in 1 BOX02/19/201412/31/2021
11 mL in 1 PACKET; Type 0: Not a Combination Product
2NDC: 59316-114-25118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/19/2014
3NDC: 59316-114-30473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/19/2014
4NDC: 59316-114-1089 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/19/2014
Labeler - Performance Health LLC (794324061)
Establishment
NameAddressID/FEIBusiness Operations
American Spraytech, LLC137135237pack(59316-114)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services LLC557434805manufacture(59316-114)

Revised: 10/2019
 
Performance Health LLC


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.