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Biofreeze Colorless Roll-On

Dosage form: gel
Ingredients: MENTHOL 40mg in 1mL
Labeler: Performance Health Inc.
NDC Code: 59316-206

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 Colorless Roll-On

Drug Facts


Active Ingredients

Menthol 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.

Stop use and ask a doctor if:

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

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

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Arctium Lappa Root (Burdock) Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Carbomer, Camellia Sinensis (Green Tea) Leaf Extract, Camphor, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Water

Questions or Comments

info@biofreeze.com or 800-246-3733

BIOFREEZE COLD THERAPY PAIN RELIEF COLORLESS ROLL-ON for arthritis, back pain, sore muscles and joints SOOTHING MENTHOL - VANISHING SCENT - PARABEN-FREE 3 fl oz / 89 mL SHAKE WELL BEFORE EACH USE Apply by rolling in only one direction. Do not use a circular motion. NO NSAIDS, IBUPROFEN, ASPIRIN OR SALICYLATE Manufactured in the U.S.A. No Animal Testing

Package Labeling:

BIOFREEZE COLORLESS ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-206
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARNICA MONTANA FLOWER 
FRANKINCENSE 
CALENDULA OFFICINALIS FLOWER 
GREEN TEA LEAF 
GLYCERIN 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
ISOPROPYL MYRISTATE 
MELISSA OFFICINALIS LEAF 
SILICON DIOXIDE 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:59316-206-101 BOTTLE, WITH APPLICATOR in 1 CARTON
189 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/17/2013
Labeler - Performance Health Inc. (794324061)
Establishment
NameAddressID/FEIOperations
Span Packaging Services LLC557434805manufacture(59316-206)

 
Performance Health Inc.

Medically reviewed on Feb 19, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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