Biofreeze roll-on gel

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, Blue 1, Yellow 5

Questions or comments

info@biofreeze.com or 800-246-3733

Ingredients and appearance - Product information

Biofreeze roll-on gel- Menthol

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 61786-799
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Menthol ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 40 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
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)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Melissa officinalis leaf ( UNII: 50D2ZE9219)
.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)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 61786-799-35 89mL in 1 BOTTLE, WITH APPLICATOR 2016/07/28

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA 2016/07/28

Labeler - REMEDYREPACK INC.( 829572556)