BIOFREEZE COLORLESS- menthol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Menthol 4%, Cooling Pain Relief
Available from:
Performance Health LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains sprains
Authorization status:
OTC monograph not final
Authorization number:
59316-103-12, 59316-103-28

BIOFREEZE COLORLESS- menthol gel

Performance Health LLC

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 Colorless 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 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; Store in a cool dry place

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 four

times daily; massage not necessary

Children under 2 years of age: Consult physician

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract,

Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract,

Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl

Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate,

Triethanolamine, Water

Questions or Comments

1-800-246-3733

Package Labeling:

BIOFREEZE COLORLESS

menthol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 316 -10 3

Route of Administration

TOPICAL

Performance Health LLC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

40 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

ARCTIUM LAPPA RO O T (UNII: 59 7E9 BI3Z3)

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

FRANKINCENSE (UNII: R9 XLF1R1WM)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

GLYCERIN (UNII: PDC6 A3C0 OX)

ILEX PARAGUARIENSIS LEAF (UNII: 1Q9 53B4O4F)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

MELISSA O FFICINALIS LEAF (UNII: 50 D2ZE9 219 )

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

TRO LAMINE (UNII: 9 O3K9 3S3TK)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 316 -10 3-12

8 9 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /19 /20 16

2

NDC:59 316 -10 3-28

273 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /19 /20 16

12/31/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 9 /19 /20 16

Labeler -

Performance Health LLC (794324061)

Revised: 6/2019

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