Biofreeze Roll-On

Biofreeze Roll-On

Drug Labeling and Warnings

Drug Details

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BIOFREEZE ROLL-ON- menthol gel 
Performance Health Inc.

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 Roll-On

Drug Facts


Active Ingredients

Menthol USP 4%

Purpose

Cooling Pain Relief

Uses:

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

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have:

Sensitive skin

When using this product:

  • Avoid contact with 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 skin 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 and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
Children under 2 years of age: Consult physician

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Arctium Lappa Root (Burdock) Extract, Boswellia Carteril Resin Extract, Calendula Officinallis Extract, Carbomer, Camellia Sinensis (Green Tea) Leaf Extract, Camphor USP, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Ispropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silicon Dioxide, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Purified Water USP, Blue 1, Yellow 5

Questions or Comments

1-800-246-3733

Package Labeling:

Label10

BIOFREEZE ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59316-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 59316-205-101 in 1 CARTON01/17/2013
189 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2NDC: 59316-205-1474 mL in 1 BOTTLE; Type 0: Not a Combination Product01/17/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/17/2013
Labeler - Performance Health Inc. (794324061)

Revised: 10/2019
 
Performance Health Inc.


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