BIOFREEZE by RB Health (US) LLC BIOFREEZE- menthol gel

BIOFREEZE by

Drug Labeling and Warnings

BIOFREEZE by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 the 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 irritated 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 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
  

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 Leaf Extract , Camphor USP, Glycerin, Ilex Paraguariensis Leaf Extract (Green Tea), Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silicon Dioxide, Tocopheryl (Vitamine E) Acetate, Triethanolamine, Purified Water USP, Blue 1, Yellow 5

Questions or Comments

 1-800-246-3733

Representative Labeling

INGREDIENTS AND APPEARANCE

BIOFREEZE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
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)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-102-10	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2012
2	NDC: 59316-102-11	3 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2012
3	NDC: 59316-102-15	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/03/2012	12/31/2018
4	NDC: 59316-102-20	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2012
5	NDC: 59316-102-25	118 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/03/2012	12/31/2021
6	NDC: 59316-102-30	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2012
7	NDC: 59316-102-40	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2012
8	NDC: 59316-102-50	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/03/2012
9	NDC: 59316-102-98	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2012
10	NDC: 59316-102-80	44 mL in 1 TUBE; Type 0: Not a Combination Product	11/02/2018
11	NDC: 59316-102-12	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2016
12	NDC: 59316-102-16	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/19/2016	12/31/2019
13	NDC: 59316-102-28	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/03/2012

Labeler - Performance Health LLC (794324061)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		117101131	manufacture(59316-102)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		557434805	manufacture(59316-102)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		825646862	manufacture(59316-102)