Biofreeze Roll-On by REMEDYREPACK INC. Biofreeze Roll-On

Biofreeze Roll-On by

Drug Labeling and Warnings

Biofreeze Roll-On by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOFREEZE ROLL-ON- menthol gel 
REMEDYREPACK 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.

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

OUTER PACKAGING: 1 in 1 CARTON

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

Remedy_Label

BIOFREEZE ROLL-ON 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70518-0068(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
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70518-0068-01 in 1 CARTON12/15/201605/15/2018
189 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/15/201605/15/2018
Labeler - REMEDYREPACK INC. (829572556)

Revised: 11/2019
Document Id: 984ea53d-ca1a-c2bd-e053-2a95a90a74ee
Set id: 6fdd10ef-0a42-4908-9f44-89053f1aa1c3
Version: 6
Effective Time: 20191127
 
REMEDYREPACK INC.