Biofreeze by RB Health (US) LLC / Span Packaging Services dba Multi-Pack Solutions BIOFREEZE- menthol gel

Biofreeze by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Menthol USP 3.5%

Purpose

Cooling Pain Reliever

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis - backache - strains - sprain

Warnings

For external use only.

Flammable

Keep away from excessive heat or open flame

Ask a doctor before use if you have:

sensitive skin

• 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 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 of 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 the 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 INGREDIENT

• carbomer, FD and C blue # 1, FD and C yellow # 5, glycerine, herbal extract (llex paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol, silicon dioxide, triethanolamine, purified water U

Questions or Comments?

1-330-633-8460

BIOFREEZE - menthol gel (

59316-101-10)

BIOFREEZE - menthol gel (

59316-101-11)

BIOFREEZE - menthol gel (

59316-101-13)

BIOFREEZE - menthol gel (

59316-101-12)

BIOFREEZE - menthol gel (

59316-101-15)

BIOFREEZE - menthol gel (

59316-101-20)

BIOFREEZE - menthol gel (

59316-101-30)

BIOFREEZE - menthol gel (

59316-101-50)

BIOFREEZE - menthol gel (

59316-101-40)

INGREDIENTS AND APPEARANCE

BIOFREEZE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-101-10	5 mL in 1 PACKET; Type 0: Not a Combination Product	08/25/2016
2	NDC: 59316-101-15	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	08/25/2016
3	NDC: 59316-101-20	118 mL in 1 TUBE; Type 0: Not a Combination Product	08/25/2016
4	NDC: 59316-101-21	81 mL in 1 TUBE; Type 0: Not a Combination Product	08/25/2016	12/31/2018
5	NDC: 59316-101-30	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/25/2016
6	NDC: 59316-101-40	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/25/2016
7	NDC: 59316-101-50	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/25/2016
8	NDC: 59316-101-25	118 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	08/25/2016
9	NDC: 59316-101-12	59 mL in 1 TUBE; Type 0: Not a Combination Product	08/25/2016
10	NDC: 59316-101-13	59 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	08/25/2016
11	NDC: 59316-101-11	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/25/2016

Labeler - Performance Health LLC. (794324061)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services LLC		117101131	manufacture(59316-101)

Establishment
Name	Address	ID/FEI	Business Operations
Span Packaging Services dba Multi-Pack Solutions		557434805	manufacture(59316-101)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence,LLC		825646862	manufacture(59316-101)