BIOFREEZE- menthol spray

Biofreeze by

Drug Labeling and Warnings

Biofreeze by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC, Span Packaging services LLC dba Multi-Pack Solutions, Span Packaging Services LLC dba Multi-Pack Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Menthol USP 10%

Purpose

Cooling Pain Reliever

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 damages skin -Do not use with other ointments, creams, sprays or liniments -Do not apply to irritated skin or if excessive 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 breastfeeding:

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 / Children 12 years and older: Apply on to affected area up to 4 times daily

Children under 12 years of age: Consult a physician

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone (MSM), Echinacea, Ethanol,  Lex Paraguarenis, Isopropyl Myristate, Juniper Berry, Purified Water USP, White Tea

Questions or Comments?

1-800-246-3733

BIOFREEZE - menthol spray (

59316-104-10)

BIOFREEZE - menthol spray (

59316-104-30)

59316-104-25 Package Label

INGREDIENTS AND APPEARANCE

BIOFREEZE 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA (UNII: O80TY208ZW)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
ALCOHOL (UNII: 3K9958V90M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
JUNIPERUS COMMUNIS WHOLE (UNII: 464910T5N9)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-104-10	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/25/2016
2	NDC: 59316-104-20	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/25/2016
3	NDC: 59316-104-30	473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/25/2016
4	NDC: 59316-104-25	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/29/2012	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/01/2010

Labeler - Performance Health LLC (794324061)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC dba Multi-Pack Solutions		117101131	manufacture(59316-104)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging services LLC		557434805	manufacture(59316-104)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC.		825646862	manufacture(59316-104)