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Biofreeze Roll-On by REMEDYREPACK INC.

Dosage form: gel
Ingredients: MENTHOL 40mg in 1mL
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0068

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 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.

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

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

Other Information:

Store in a cool dry place with lid closed tightly

Questions or Comments

1-800-246-3733

PRINCIPAL DISPLAY PANEL

DRUG: Biofreeze Roll-On

GENERIC: MENTHOL

DOSAGE: GEL

ADMINSTRATION: TOPICAL

NDC: 70518-0068-0

PACKAGING: 89 mL in 1 BOTTLE, WITH APPLICATOR

ACTIVE INGREDIENT(S):

  • MENTHOL 40mg in 1mL

INACTIVE INGREDIENT(S):

  • ARNICA MONTANA FLOWER
  • GREEN TEA LEAF
  • CALENDULA OFFICINALIS FLOWER
  • GLYCERIN
  • FRANKINCENSE
  • ISOPROPYL MYRISTATE
  • ILEX PARAGUARIENSIS LEAF
  • ISOPROPYL ALCOHOL
  • .ALPHA.-TOCOPHEROL ACETATE
  • TROLAMINE
  • FD&C BLUE NO. 1
  • WATER
  • ALOE VERA LEAF
  • FD&C YELLOW NO. 5
  • MELISSA OFFICINALIS LEAF
  • SILICON DIOXIDE

BIOFREEZE ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0068(NDC:59316-205)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE 
MELISSA OFFICINALIS LEAF 
SILICON DIOXIDE 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
WATER 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
ALOE VERA LEAF 
ARNICA MONTANA FLOWER 
FRANKINCENSE 
CALENDULA OFFICINALIS FLOWER 
GREEN TEA LEAF 
GLYCERIN 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:70518-0068-089 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/15/2016
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Medically reviewed on Dec 28, 2017

Further information

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

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